scholarly journals Improving Airways Patency and Ventilation Through Optimal Positive Pressure Identified by Noninvasive Mechanical Ventilation Titration in Mounier-Kuhn Syndrome: Protocol for an Interventional, Open-Label, Single-Arm Clinical Trial (Preprint)

2019 ◽  
Author(s):  
Evelise Lima ◽  
Maria Aparecida Miyuki Nakamura ◽  
Pedro Rodrigues Genta ◽  
Ascedio José Rodrigues ◽  
Rodrigo Abensur Athanazio ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Treatment Options ◽  
Pulmonary Ventilation ◽  
Airflow Obstruction ◽  
Positive Pressure ◽  
Hypertonic Solution ◽  
Research Database ◽  
Forced Expiration ◽  
Open Label ◽  
Obstructive Sleep

BACKGROUND Mounier-Kuhn syndrome or congenital tracheobronchomegaly is a rare disease characterized by dilation of the trachea and the main bronchi within the thoracic cavity. The predominant signs and symptoms of the disease include coughing, purulent and abundant expectoration, dyspnea, snoring, wheezing, and recurrent respiratory infection. Symptoms of the disease in some patients are believed to be pathological manifestations arising due to resident tracheobronchomalacia. Although treatment options used for the management of this disease include inhaled bronchodilators, corticosteroids, and hypertonic solution, there is no consensus on the treatment. The use of continuous positive airway pressure (CPAP) has been reported as a potential therapeutic option for tracheobronchomalacia, but no prospective studies have demonstrated its efficacy in this condition. OBJECTIVE The purpose of this is to identify the presence of tracheobronchomalacia and an optimal CPAP pressure that reduces the tracheobronchial collapse in patients with Mounier-Kuhn syndrome and to analyze the repercussion in pulmonary ventilation. In parallel, we aim to evaluate the prevalence of obstructive sleep apnea/hypopnea syndrome. METHODS This interventional, open-label, single-arm clinical trial will enroll patients who are diagnosed Mounier-Kuhn syndrome. Patient evaluation will be conducted in an outpatient clinic and involve 3 visits. Visit 1 will involve the collection and registration of social demographic, clinical, and functional data. Visit 2 will entail polysomnography, bronchoscopy for the evaluation of tracheobronchomalacia, titration of the optimal pressure that reduces the degree of collapse of the airway, and electrical impedance tomography. In visit 3, patients exhibiting a reduction in collapse areas will be requested to undergo chest computed tomography during inspiration and forced expiration with and without positive pressure (titrated to determine optimal CPAP pressure). RESULTS This protocol is a doctorate project. The project was submitted to the institutional review board on January 24, 2017, and approval was granted on February 2, 2017 (Brazilian Research database number CAAE 64001317.4.000.0068). Patient evaluations started in April 2018. Planned recruitment is based on volunteers’ availability and clinical stability, and interventions will be conducted at least once a month to finish the project at the end of 2020. A preliminary analysis of each case will be performed after each intervention, but detailed results are expected to be reported in the first quarter of 2021. CONCLUSIONS There is no consensus on the best treatment options for managing Mounier-Kuhn syndrome. The use of positive pressure could maintain patency of the collapsed airways, functioning as a “pneumatic stent” to reduce the degree of airflow obstruction. This, in turn, could promote mobilization of thoracic secretion and improve pulmonary ventilation. CLINICALTRIAL ClinicalTrails.gov NCT03101059; https://clinicaltrials.gov/ct2/show/NCT03101059. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/14786

scholarly journals Improving Airways Patency and Ventilation Through Optimal Positive Pressure Identified by Noninvasive Mechanical Ventilation Titration in Mounier-Kuhn Syndrome: Protocol for an Interventional, Open-Label, Single-Arm Clinical Trial

10.2196/14786 ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. e14786
Author(s):  
Evelise Lima ◽  
Maria Aparecida Miyuki Nakamura ◽  
Pedro Rodrigues Genta ◽  
Ascedio José Rodrigues ◽  
Rodrigo Abensur Athanazio ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Treatment Options ◽  
Pulmonary Ventilation ◽  
Airflow Obstruction ◽  
Positive Pressure ◽  
Hypertonic Solution ◽  
Research Database ◽  
Forced Expiration ◽  
Open Label ◽  
Obstructive Sleep

Background Mounier-Kuhn syndrome or congenital tracheobronchomegaly is a rare disease characterized by dilation of the trachea and the main bronchi within the thoracic cavity. The predominant signs and symptoms of the disease include coughing, purulent and abundant expectoration, dyspnea, snoring, wheezing, and recurrent respiratory infection. Symptoms of the disease in some patients are believed to be pathological manifestations arising due to resident tracheobronchomalacia. Although treatment options used for the management of this disease include inhaled bronchodilators, corticosteroids, and hypertonic solution, there is no consensus on the treatment. The use of continuous positive airway pressure (CPAP) has been reported as a potential therapeutic option for tracheobronchomalacia, but no prospective studies have demonstrated its efficacy in this condition. Objective The purpose of this is to identify the presence of tracheobronchomalacia and an optimal CPAP pressure that reduces the tracheobronchial collapse in patients with Mounier-Kuhn syndrome and to analyze the repercussion in pulmonary ventilation. In parallel, we aim to evaluate the prevalence of obstructive sleep apnea/hypopnea syndrome. Methods This interventional, open-label, single-arm clinical trial will enroll patients who are diagnosed Mounier-Kuhn syndrome. Patient evaluation will be conducted in an outpatient clinic and involve 3 visits. Visit 1 will involve the collection and registration of social demographic, clinical, and functional data. Visit 2 will entail polysomnography, bronchoscopy for the evaluation of tracheobronchomalacia, titration of the optimal pressure that reduces the degree of collapse of the airway, and electrical impedance tomography. In visit 3, patients exhibiting a reduction in collapse areas will be requested to undergo chest computed tomography during inspiration and forced expiration with and without positive pressure (titrated to determine optimal CPAP pressure). Results This protocol is a doctorate project. The project was submitted to the institutional review board on January 24, 2017, and approval was granted on February 2, 2017 (Brazilian Research database number CAAE 64001317.4.000.0068). Patient evaluations started in April 2018. Planned recruitment is based on volunteers’ availability and clinical stability, and interventions will be conducted at least once a month to finish the project at the end of 2020. A preliminary analysis of each case will be performed after each intervention, but detailed results are expected to be reported in the first quarter of 2021. Conclusions There is no consensus on the best treatment options for managing Mounier-Kuhn syndrome. The use of positive pressure could maintain patency of the collapsed airways, functioning as a “pneumatic stent” to reduce the degree of airflow obstruction. This, in turn, could promote mobilization of thoracic secretion and improve pulmonary ventilation. Trial Registration ClinicalTrails.gov NCT03101059; https://clinicaltrials.gov/ct2/show/NCT03101059. International Registered Report Identifier (IRRID) DERR1-10.2196/14786

scholarly journals Clinical trial protocol to evaluate the efficacy of cefixime in the treatment of early syphilis

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Shivani N. Mehta ◽  
Chrysovalantis Stafylis ◽  
David M. Tellalian ◽  
Pamela L. Burian ◽  
Cliff M. Okada ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Los Angeles ◽  
Hiv Infection ◽  
Treatment Options ◽  
Post Treatment ◽  
Penicillin G ◽  
Benzathine Penicillin ◽  
Open Label ◽  
Early Syphilis ◽  
Recommended Treatment

Abstract Background Syphilis rates have been increasing both in the USA and internationally with incidence higher among men-who-have-sex-with-men and people living with human immunodeficiency virus (HIV) infection. Currently, benzathine penicillin is the recommended treatment for syphilis in all patients. Global shortages and cost increases in benzathine penicillin call for alternative treatment options. This study evaluates the efficacy of oral cefixime for the treatment of early syphilis. Methods We are conducting a randomized, multisite, open-label, non-comparative clinical trial in Los Angeles and Oakland, CA. Eligible participants are ≥ 18 years old, with primary, secondary, or early latent syphilis (rapid plasma reagin [RPR] titer ≥ 1:8). Patients with HIV infection must have a viral load ≤ 200 copies/mL and CD4+ T cell count ≥ 350 cells/μL during the past 6 months. Participants are randomized to receive either 2.4 M IU benzathine penicillin G intramuscularly once or cefixime 400 mg orally twice a day for 10 days. Participants return at 3, 6, and 12 months post-treatment for follow-up RPR serological testing. The primary outcome is the proportion of participants who achieve ≥ 4-fold RPR titer decrease at 3 or 6 months post-treatment. Discussion Clinical trials evaluating the efficacy of alternative antibiotics to penicillin are urgently needed. Trial registration Clinicaltrials.gov NCT03660488. Registered on 4 September 2018.

scholarly journals Clinical Trial Protocol to Evaluate the Efficacy of Cefixime in the Treatment of Early Syphilis

2020 ◽  
Author(s):  
Shivani N. Mehta ◽  
Chrysovalantis Stafylis ◽  
David M. Tellalian ◽  
Pamela L. Burian ◽  
Cliff M. Okada ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Los Angeles ◽  
Hiv Infection ◽  
Treatment Options ◽  
Post Treatment ◽  
Penicillin G ◽  
Benzathine Penicillin ◽  
Open Label ◽  
Early Syphilis ◽  
Recommended Treatment

Abstract Background: Syphilis rates have been increasing both in the US and internationally with incidence higher among men-who-have-sex-with-men and people living with human immunodeficiency virus (HIV) infection. Currently, benzathine penicillin is the recommended treatment for syphilis in all patients. Global shortages and cost increases in benzathine penicillin call for alternative treatment options. This study evaluates the efficacy of oral cefixime for the treatment of early syphilis. Methods: We are conducting a randomized, multisite, open-label, non-comparative clinical trial in Los Angeles and Oakland, California. Eligible participants are ≥18 years old, with primary, secondary or early latent syphilis (Rapid Plasma Reagin [RPR] titer ≥1:8). Patients with HIV infection must have a viral load ≤200 copies/mL and CD4+ T cell count ≥350 cells/μl during the past 6 months. Participants are randomized to receive either 2.4M IU benzathine penicillin G intramuscularly once or cefixime 400mg orally twice a day for 10 days. Participants return at 3, 6, and 12 months post-treatment for follow-up RPR serological testing. The primary outcome is the proportion of participants who achieve ≥4-fold RPR titer decrease at 3- or 6-months post-treatment.Discussion: Clinical trials evaluating the efficacy of alternative antibiotics to penicillin are urgently needed. Trial Registration: Clinicaltrials.gov, NCT03660488. Registered September 4, 2018, https://clinicaltrials.gov/ct2/show/NCT03660488

FRACTION (Fast Real-time Assessment of Combination Therapies in Immuno-Oncology)-gastric cancer (GC): A randomized, open-label, adaptive, phase 2 study of nivolumab in combination with other immuno-oncology (IO) agents in patients with advanced GC.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS4137-TPS4137 ◽  
Author(s):  
Praveen Aanur ◽  
Martin Gutierrez ◽  
Ronan Joseph Kelly ◽  
Jaffer A. Ajani ◽  
Geoffrey Yuyat Ku ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Rapid Development ◽  
Treatment Options ◽  
Gastroesophageal Junction ◽  
Objective Response ◽  
Progression Free Survival ◽  
New Combination ◽  
Clinical Activity ◽  
Phase 2 ◽  
Open Label

TPS4137 Background: Nivolumab, a fully human IgG4 mAb that targets programmed death-1, alone and in combination with ipilimumab, a fully human IgG1 mAb that targets cytotoxic T-lymphocyte antigen 4, has demonstrated encouraging clinical activity in patients with advanced GC. These data support the rationale that nivolumab in combination with other IO agents or targeted therapies may improve treatment outcomes in patients with advanced GC. Given the rapid development of novel IO agents, traditional studies cannot efficiently evaluate all possible IO-IO and IO-targeted therapy combinations. FRACTION is an innovative clinical trial program with a rolling, adaptive platform design that allows for the addition of new combination regimens, as well as withdrawal of ineffective regimens. Here we describe the study concept, key design components, and the first IO treatment combinations of FRACTION-GC, a phase 2, randomized, open-label, adaptive study in advanced GC (NCT02935634). Methods: Patients with advanced GC or gastroesophageal junction (GEJ) cancer will be enrolled based on prior IO treatment and randomized to receive nivolumab plus BMS-986016 (fully human IgG4 mAb that targets lymphocyte activation gene 3) or nivolumab plus ipilimumab. Enrollment is continuous and may offer patients consecutive treatment options based on their treatment exposure and response. The primary endpoints are objective response rate, duration of response, and progression-free survival rate at 24 weeks. The secondary endpoint is safety. Comprehensive biomarker analyses will also be performed. New treatment combinations will be added over time to explore their potential benefits and to provide a continuous flow of treatment options for patients whose cancer progresses on existing treatments. In this way, FRACTION-GC is envisioned to accelerate the development of the next generation of IO combinations for patients with metastatic GC and GEJ cancer. Clinical trial information: NCT02935634.

scholarly journals Clinical Trial Protocol to Evaluate the Efficacy of Cefixime in the Treatment of Early Syphilis

2020 ◽  
Author(s):  
Shivani N. Mehta ◽  
Chrysovalantis Stafylis ◽  
David M. Tellalian ◽  
Pamela L. Burian ◽  
Cliff M. Okada ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Los Angeles ◽  
Hiv Infection ◽  
Treatment Options ◽  
Post Treatment ◽  
Penicillin G ◽  
Benzathine Penicillin ◽  
Open Label ◽  
Early Syphilis ◽  
Recommended Treatment

Abstract Background: Syphilis rates have been increasing both in the US and internationally with incidence higher among men-who-have-sex-with-men and people living with human immunodeficiency virus (HIV) infection. Currently, benzathine penicillin is the recommended treatment for syphilis in all patients. Global shortages and cost increases in benzathine penicillin call for alternative treatment options. This study evaluates the efficacy of oral cefixime for the treatment of early syphilis. Methods: We are conducting a randomized, multisite, open-label, non-comparative clinical trial in Los Angeles and Oakland, California. Eligible participants are ≥18 years old, with primary, secondary or early latent syphilis (Rapid Plasma Reagin [RPR] titer ≥1:8). Patients with HIV infection must have a viral load ≤200 copies/mL and CD4+ T cell count ≥350 cells/μl during the past 6 months. Participants are randomized to receive either 2.4M IU benzathine penicillin G intramuscularly once or cefixime 400mg orally twice a day for 10 days. Participants return at 3, 6, and 12 months post-treatment for follow-up RPR serological testing. The primary outcome is the proportion of participants who achieve ≥4-fold RPR titer decrease at 3- or 6-months post-treatment.Discussion: Clinical trials evaluating the efficacy of alternative antibiotics to penicillin are urgently needed. Trial Registration: Clinicaltrials.gov, NCT03660488. Registered September 4, 2018, https://clinicaltrials.gov/ct2/show/NCT03660488

728 Sleep Apnea Screening in Inpatients Admitted with Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A feasibility study

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A284-A284
Author(s):  
Alejandra Lastra ◽  
Veronica Esmero ◽  
James Herdegen ◽  
Colleen Durkin
Keyword(s):  
Sleep Apnea ◽  
Acute Exacerbation ◽  
Airflow Obstruction ◽  
Overlap Syndrome ◽  
Positive Pressure ◽  
Chronic Obstructive ◽  
Portable Monitoring ◽  
Arterial Blood ◽  
Obstructive Sleep ◽  
Number Of Patients

Abstract Introduction Obstructive sleep apnea (OSA) and Chronic obstructive airway disease (COPD) affect millions of Americans. The combination (overlap syndrome) results in increased morbidity, mortality and associated healthcare costs. Type III sleep testing via portable monitoring (PM) is not recommended for patients with COPD, and there is little guidance in regards to inpatient testing. We aim to determine the feasibility of inpatient PM for diagnosing OSA in patients admitted with acute exacerbation of COPD (AECOPD) and hypercapnic respiratory failure requiring noninvasive positive pressure ventilation (NIPPV). Methods This is a retrospective review of prospectively collected data. Inpatients 40 year-old and older admitted with AECOPD and PaCO2≥52mmHg on arterial blood gas (ABG) testing requiring NIPPV were included for analysis. One patient died and one withdrew consent. The remaining patients underwent overnight PM (ApneaLink Airtm by ResMed®) once clinically stable, off NIPPV, on oxygen when needed to sustain oxygen saturation at or above 88%. Patients were discharged on volume-assured pressure support ventilation (VAPS) for nightly use at home and followed for 6 months. Results Five patients were included. Average age was 60 years, majority were African-American males, former smokers (average 31.2 pack-years), with moderate to severe airflow obstruction (FEV1 24–52 %Pred). Except for one (BMI 17 kg/m2), patients had concomitant morbid obesity (average BMI 39.7 kg/m2). Four out of 5 patients had overlap syndrome (AHI 19.4/h -75/h). Follow-up objective download data demonstrated AHI <10 in all patients with available data (3/5 at 6 months). One patient required in-sleep center VAPS titration. Conclusion This pilot study suggests portable monitoring is feasible in diagnosing OSA in this complex patient population admitted for AECOPD, despite concomitant oxygen use during PM testing. Despite the small number of patients, 4/5 were diagnosed with moderate to severe OSA and objective data on VAPS demonstrated effective treatment. Further studies using PM for screening of OSA in inpatients with COPD and obesity and impact on patient-centric outcomes are needed. Support (if any):

The application of electronic medical records (EMRs) as a virtual comparator arm in a lung cancer clinical trial: A case study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18098-e18098
Author(s):  
Ketan Patel ◽  
Mario Ouwens ◽  
Norah Shire ◽  
Sajan Khosla
Keyword(s):  
Lung Cancer ◽  
Clinical Trial ◽  
Overall Survival ◽  
Electronic Medical Records ◽  
Medical Records ◽  
Cox Regression ◽  
Treatment Options ◽  
Trial Data ◽  
Open Label ◽  
Time Period

e18098 Background: Single-arm and open-label clinical studies are common in oncology drug development, leading to a frequent need for contextualization of results and provision of other means of comparison for cost-effectiveness models. The utility of current approaches such as naïve comparisons, historical control benchmarking, and match-adjusted interventional controls is limited. An alternative approach is the use of routinely collected data from Electronic Medical Records (EMRs). This study sought to determine if overall survival (OS) in advanced non-small cell lung cancer patients from a clinical trial comparator arm could be replicated using EMR data. Methods: De-identified EMR-derived patient data from Flatiron Health were matched via propensity scores to Project Data Sphere clinical trial data for study NCT00457392 of sunitinib plus erlotinib versus erlotinib alone to compare overall survival outcomes. A Cox regression model stratified for dataset was used to estimate the hazard ratio and 95% confidence interval for OS. Results: The Kaplan Meier curves were comparable for the first period after start of treatment, but differed after median survival was reached, with the Flatiron dataset achieving longer median OS. This deviation was strongly associated with differences in post-erlotinib treatment options introduced between the clinical trial period and the EMR period. Splitting the Flatiron data in two, related to the period from which the data were obtained (pre- or post-2013), resulted in a better match for the period closer to the trial [HR: 1.12 (0.93,1.35), P = 0.219] than for the later period [HR: 1.23 (1.01,1.5), P = 0.039]. Conclusions: Our results demonstrate that the time period in which EMR data are collected is important when matching to trial data. EMR data can contextualize the OS benefit for single-arm or uncontrolled trials run in the same time period. Further exploration of time-varying effects on OS is warranted.

Phase II clinical trial of novel agent PBI-05204 in patients with metastatic pancreatic adenocarcinoma (mPDA).

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 698-698
Author(s):  
Marc Thomas Roth ◽  
Dana Backlund Cardin ◽  
Erkut Hasan Borazanci ◽  
Margaux Steinbach ◽  
Vincent J. Picozzi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Primary Endpoint ◽  
Treatment Options ◽  
Objective Response ◽  
Progression Free Survival ◽  
Tumor Burden ◽  
Nerium Oleander ◽  
Orthotopic Model ◽  
Open Label

698 Background: Survival statistics for mPDA are dismal and with limited treatment options novel agents are needed to improve disease outcomes. PBI-05204 (Phoenix Biotechnology, Inc., San Antonio, TX) is a modified supercritical carbon dioxide extract of Nerium oleander leaves. Oleandrin, the extract’s major cytotoxic component, has demonstrated anti-tumor activity in various tumor cell lines. In a human PDA orthotopic model, this preparation reduced tumor burden as monotherapy. Pharmacodynamic studies suggest that PBI-05204’s mechanism of action is through inhibition of the PI3k/Akt/mTOR pathway. Methods: A phase II single-arm, open-label study to determine the efficacy of PBI-05204 in patients (pts) with mPDA refractory to standard therapy was conducted. The primary endpoint was overall survival (OS) with the hypothesis that 50% of pts would be alive at 4.5 months. Secondary objectives included safety, progression-free survival (PFS), and overall response rate. Pts received oral PBI-05204 daily until progressive disease (PD), unacceptable toxicity, or pt withdrawal. Radiographic response was assessed every two cycles. Results: Forty-one pts were enrolled; two never received treatment and one was found to have a neuroendocrine tumor after pathological re-evaluation, leaving 38 pts for analysis. Median age at time of enrollment was 65.0 years. The median time from initial diagnosis to treatment was 16.9 months. The primary reason for withdrawal was PD (45.2%). Ten pts were alive at 4.5 months (26.3%) with a mPFS of 56 days (corresponding to first restaging). One objective response (2.6%) was observed for 162 days. Grade ≥3 treatment-emergent adverse events occurred in 63.2% of pts with the most common attributed to drug (all grades) being fatigue (36.8%), vomiting (23.7%), nausea (18.4%), decreased appetite (18.4%), and diarrhea (15.8%). Conclusions: PBI-05204 did not meet its primary endpoint for OS in this study. Recent preclinical data indicate an efficacious role for PBI-05204 against glioblastoma multiforme when combined with chemotherapy, such as temozolomide, and radiotherapy. A randomized Phase II trial is currently being designed. Clinical trial information: NCT02329717.

scholarly journals A Pilot Randomized Clinical Trial: Oral Miltefosine and Pentavalent Antimonials Associated With Pentoxifylline for the Treatment of American Tegumentary Leishmaniasis

2021 ◽  
Vol 11 ◽  
Author(s):  
Sofia Sales Martins ◽  
Daniel Holanda Barroso ◽  
Bruna Côrtes Rodrigues ◽  
Jorgeth de Oliveira Carneiro da Motta ◽  
Gustavo Subtil Magalhães Freire ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Treatment Options ◽  
Treatment Interruption ◽  
Control Group ◽  
Open Label ◽  
Need For Treatment ◽  
Tegumentary Leishmaniasis ◽  
Wide Range ◽  
American Tegumentary Leishmaniasis

IntroductionAmerican tegumentary leishmaniasis (ATL), which can present as either cutaneous (CL) or mucosal leishmaniasis (ML), is endemic in South America, and first-line antimonial treatments are known for their wide range of adverse effects (AEs). Growing reports of drug resistance increase the urgency of the need for better treatment options. The objective of this pilot clinical trial was to assess the efficacy of and AEs associated with the oral combination of miltefosine and pentoxifylline based on a post hoc analysis.MethodsA pilot, randomized, open-label clinical trial was performed. The experimental group (M+P) received 50 mg twice a day (BID) miltefosine and 400 mg three times a day (TID) pentoxifylline, and the control group (A+P) received 20 mg Sb+V/kg/day intravenously and 400 mg TID pentoxifylline. Patients with ML received treatment for 28 days, and patients with CL received treatment for 20 days.ResultsForty-three patients were included: 25 with ML and 18 with CL caused by L.(V.) braziliensis. AEs were more frequent in the A+P group (p=0.322), and there was a need for treatment interruption due to severe AEs (p=0.027). Patients with CL had a higher chance of achieving a cure (p=0.042) and a higher risk of AEs (p=0.033). There was no difference in the chance of a cure based on the treatment (p=0.058).ConclusionIn this pilot randomized clinical trial, M+P treatment and A+P treatment yielded similar cure rates, and the former was associated with a lower risk of AEs. Future studies with more patients and longer follow-up are recommended.

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