scholarly journals An open label randomized controlled trial of tamoxifen combined with amphotericin B and fluconazole for cryptococcal meningitis

eLife ◽  
2021 ◽  
Vol 10 ◽  
Author(s):  
Nguyen Thi Thuy Ngan ◽  
Nhat Thanh Hoang Le ◽  
Nguyen Ngo Vi Vi ◽  
Ninh Thi Thanh Van ◽  
Nguyen Thi Hoang Mai ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cryptococcal Meningitis ◽  
Standard Care ◽  
Therapeutic Potential ◽  
Controlled Trial ◽  
High Dose ◽  
Open Label ◽  
Randomized Controlled ◽  
Cancer Agent

Background: Cryptococcal meningitis has high mortality. Flucytosine is a key treatment but is expensive and rarely available. The anti-cancer agent tamoxifen has synergistic anti-cryptococcal activity with amphotericin in vitro. It is off-patent, cheap, and widely available. We performed a trial to determine its therapeutic potential.Methods:Open label randomized controlled trial. Participants received standard care - amphotericin combined with fluconazole for the first two weeks - or standard care plus tamoxifen 300mg/day. The primary end point was Early Fungicidal Activity (EFA) - the rate of yeast clearance from cerebrospinal fluid (CSF). Trial registration https://clinicaltrials.gov/ct2/show/NCT03112031 .Results: 50 patients were enrolled, (median age 34 years, 35 male). Tamoxifen had no effect on EFA (- 0.48log10 colony-forming units/mL/CSF control arm versus -0.49 tamoxifen arm, difference - 0.005log10CFU/ml/day, 95%CI: -0.16, 0.15, P=0.95). Tamoxifen caused QTc prolongation.Conclusion: High dose tamoxifen does not increase the clearance rate of Cryptococcus from CSF. Novel, affordable therapies are needed.Funding:The trial was funded through the Wellcome Trust Asia Programme Vietnam Core Grant 106680 and a Wellcome Trust Intermediate Fellowship to JND grant number WT097147MA.

scholarly journals AYUSH-64 as an adjunct to Standard Care in mild to moderate COVID-19: An open-label randomized controlled trial in Chandigarh, India

2021 ◽  
Author(s):  
Harbans Singh ◽  
Sumit Shrivastva ◽  
Babita Yadav ◽  
Amit Kumar Rai ◽  
Sophia Jameela ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Inflammatory Markers ◽  
Standard Care ◽  
Controlled Trial ◽  
Control Group ◽  
Rt Pcr ◽  
Open Label ◽  
Clinical Recovery ◽  
Randomized Controlled ◽  
Significant Difference

Background: There is limited evidence on the safety and efficacy of administering Ayurveda interventions as add-on to the standard care for COVID-19. Objective: To explore the therapeutic efficacy and safety of AYUSH-64 as an add-on to standard care in the management of mild to moderate stage COVID-19.Design, setting, participants and interventions: This was an open-label randomized controlled trial with 80 patients of mild to moderate stage COVID-19. Participants in the AYUSH-64 add-on group received two tablets (500 mg each) three times daily for 30 days along with conventional standard care (Paracetamol, Cetirizine, Vitamin C, and Azithromycin). The control group received standard care alone. Main outcome measures: The primary outcome assessed was the proportion of participants with clinical recovery and negative RT-PCR assay for COVID-19 on day 7, 15, 23, and 30. Additionally, change in pro-inflammatory markers, metabolic functions, HRCT chest and incidence of Adverse Drug Reaction (ADR) / Serious Adverse Event (SAE) were assessed.Results: Statistically significant difference was observed in the proportion of participants with clinical recovery in the AYUSH-64 add-on group (p<0.001) at each of the scheduled follow-up visits. All the participants in the AYUSH-64 add-on group clinically recovered by day 23 compared to 32.4 per cent in the control group. The mean duration for clinical recovery in AYUSH-64 add-on group (5.8 ± 2.67 days) was less as compared to control group (10.0 ± 4.06 days). The proportion of participants who turned RT-PCR negative for COVID-19 on day 7, 15, and 23 were 81.8, 94.5, and 100 per cent in AYUSH-64 add-on group, and 79.4, 94.5, and 97.2 per cent in control group, however, the difference observed was statistically not significant (p=0.314). The proportion of participants with improvement in HRCT chest was statistically significant in AYUSH-64 add-on group (p=0.031) unlike in control group (p=0.210). Similar reductions in most inflammatory markers measured (IL-6, CRP, Serum ferritin, and LDH) on day 30 (p<0.05) were observed in both groups. Conclusion: AYUSH-64 as adjunct to standard conventional care is safe and hastens clinical recovery in adult patients with mild to moderate COVID-19.

scholarly journals A phase II randomized controlled trial adding oral flucytosine to high-dose fluconazole, with short-course amphotericin B, for cryptococcal meningitis

AIDS ◽  
2012 ◽  
Vol 26 (11) ◽  
pp. 1363-1370 ◽  
Author(s):  
Arthur T. Jackson ◽  
Jesse C. Nussbaum ◽  
Jacob Phulusa ◽  
Dan Namarika ◽  
Maria Chikasema ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Amphotericin B ◽  
Phase Ii ◽  
Cryptococcal Meningitis ◽  
Controlled Trial ◽  
High Dose ◽  
Randomized Controlled ◽  
Short Course

High dose (4mg/kg/day) versus usual dose (2mg/kg/day) oral prednisolone for treatment of infantile spasms: An open-label, randomized controlled trial

2014 ◽  
Vol 108 (8) ◽  
pp. 1378-1384 ◽  
Author(s):  
Prabaharan Chellamuthu ◽  
Suvasini Sharma ◽  
Puneet Jain ◽  
Jaya Shankar Kaushik ◽  
Anju Seth ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Oral Prednisolone ◽  
Infantile Spasms ◽  
High Dose ◽  
Open Label ◽  
Randomized Controlled ◽  
Usual Dose

scholarly journals Safety and efficacy of antiviral therapy alone or in combination in COVID-19 - a randomized controlled trial (SEV COVID Trial)

2021 ◽  
Author(s):  
◽  
Prasan Kumar Panda
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Treatment ◽  
Therapeutic Potential ◽  
Controlled Trial ◽  
Antiviral Treatment ◽  
Severe Disease ◽  
Open Label ◽  
Drug Induced ◽  
Randomized Controlled ◽  
Severe Group

Background Definitive antiviral treatment is not available for COVID-19 infection except remdesivir that even with many doubts. Various combination antivirals have been tried. Methods A single-center, open-label, parallel-arm, stratified randomized controlled trial evaluated the therapeutic potential of hydroxychloroquine and lopinavir-ritonavir in combination with ribavirin in COVID-19. Enrolled patients in severe category were randomized into three groups: A: standard treatment, B: hydroxychloroquine+ribavirin+standard treatment, or C: lopinavir+ritonavir+ribavirin+standard treatment; while non-severe category into two groups: A: standard treatment or B: hydroxychloroquine+ribavirin. Combination antivirals was given for 10 days and followed for 28 days. The primary endpoints were safety, symptomatic and laboratory recovery of organ dysfunctions, and time to SARS-CoV-2 RT-PCR negative report. Results Total 111 patients randomized: 24, 23, and 24 in severe category A, B, and C respectively, and 20 in each non-severe group. Two patients receiving ribavirin experienced drug induced liver injury and another developed QT prolongation after hydroxychloroquine. In the severe category, 47.6%, 55%, and 30.09% in A, B, and C groups respectively showed symptomatic recovery compared to 93.3% and 86.7% in A and B groups respectively in the non-severe category at 72hrs (P>0.05). Conclusions The results failed to show statistical superiority of the antiviral combination therapies to that of the standard therapy in both the severe and non-severe categories in symptomatic adult patients of COVID-19. However, results do indicate the benefit of non-standard interventional combination therapy in severe disease. Furthermore, the dose of ribavirin needs to be reconsidered in the Indian population.

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