scholarly journals Injectable Amoxicillin Versus Injectable Ampicillin Plus Gentamicin in the Treatment of Severe Pneumonia in Children Aged 2 to 59 Months: Protocol for an Open-Label Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Lubaba Shahrin ◽  
Mohammod Jobayer Chisti ◽  
Abu Sadat Mohammad Sayeem Bin Shahid ◽  
Abu Sayem Mirza Mohammad Hasibur Rahman ◽  
Md. Zahidul Islam ◽  
...  
Keyword(s):  
Hospital Stay ◽  
Diarrheal Disease ◽  
Controlled Trial ◽  
Severe Pneumonia ◽  
World Health ◽  
Open Label ◽  
Once Daily ◽  
Danger Signs ◽  
Randomized Controlled ◽  
Daily Dose

BACKGROUND Pneumonia causes about 0.9 million deaths worldwide each year. The World Health Organization (WHO) guidelines for the standard management of severe pneumonia requires parenteral ampicillin every 6 hours and once-daily parenteral gentamicin for 5 to 7 days. Although this treatment has contributed to the reduction of mortality, it requires nursing interventions every 6 hours for 7 days. Further intervention trials should be conducted to search for alternate antibiotics with better adherence, reduced cost, and reduced hospital stay. Parenteral amoxicillin is an effective alternative to ampicillin, as it has a longer half-life and broader coverage. OBJECTIVE The aim of this clinical trial is to compare the efficacy of a dose of injectable amoxicillin every 12 hours plus a once-daily dose of injectable gentamicin with a dose of injectable ampicillin every 6 hours plus a once-daily dose of injectable gentamicin in children hospitalized for severe pneumonia. METHODS This randomized, controlled, open-label, noninferiority trial is being conducted in Dhaka Hospital of the International Centre for Diarrheal Disease Research, Bangladesh. A sample size of 308 children with severe pneumonia will give adequate power to this study. Children aged 2 to 59 months are randomized to either intravenous ampicillin or intravenous amoxicillin, plus intravenous gentamicin in both study arms. The monitoring of the patients is carried out according to the WHO protocol for the treatment of severe pneumonia. The primary objective is the rate of treatment failure, defined by the persistence of danger signs of severe pneumonia beyond 48 hours or deterioration within 24 hours of initiation of the therapy. The secondary objectives are (1) improvement in or the resolution of danger signs since enrollment, (2) length of hospital stay, (3) death during hospitalization, and (4) rate of nosocomial infections. RESULTS Enrollment in the study started on January 1, 2018, and ended on October 31, 2019. Data entry and analysis are in progress. Findings from the study are expected to be disseminated in October 2020. CONCLUSIONS Our study's findings will improve compliance with the use of antibiotics that require less frequent doses for the treatment of severe pneumonia. CLINICALTRIAL ClinicalTrials.gov NCT03369093; https://clinicaltrials.gov/ct2/show/NCT03369093 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/17735

scholarly journals Injectable Amoxicillin Versus Injectable Ampicillin Plus Gentamicin in the Treatment of Severe Pneumonia in Children Aged 2 to 59 Months: Protocol for an Open-Label Randomized Controlled Trial

10.2196/17735 ◽  
2020 ◽  
Vol 9 (11) ◽  
pp. e17735
Author(s):  
Lubaba Shahrin ◽  
Mohammod Jobayer Chisti ◽  
Abu Sadat Mohammad Sayeem Bin Shahid ◽  
Abu Sayem Mirza Mohammad Hasibur Rahman ◽  
Md. Zahidul Islam ◽  
...  
Keyword(s):  
Hospital Stay ◽  
Diarrheal Disease ◽  
Controlled Trial ◽  
Severe Pneumonia ◽  
World Health ◽  
Open Label ◽  
Once Daily ◽  
Danger Signs ◽  
Randomized Controlled ◽  
Daily Dose

Background Pneumonia causes about 0.9 million deaths worldwide each year. The World Health Organization (WHO) guidelines for the standard management of severe pneumonia requires parenteral ampicillin every 6 hours and once-daily parenteral gentamicin for 5 to 7 days. Although this treatment has contributed to the reduction of mortality, it requires nursing interventions every 6 hours for 7 days. Further intervention trials should be conducted to search for alternate antibiotics with better adherence, reduced cost, and reduced hospital stay. Parenteral amoxicillin is an effective alternative to ampicillin, as it has a longer half-life and broader coverage. Objective The aim of this clinical trial is to compare the efficacy of a dose of injectable amoxicillin every 12 hours plus a once-daily dose of injectable gentamicin with a dose of injectable ampicillin every 6 hours plus a once-daily dose of injectable gentamicin in children hospitalized for severe pneumonia. Methods This randomized, controlled, open-label, noninferiority trial is being conducted in Dhaka Hospital of the International Centre for Diarrheal Disease Research, Bangladesh. A sample size of 308 children with severe pneumonia will give adequate power to this study. Children aged 2 to 59 months are randomized to either intravenous ampicillin or intravenous amoxicillin, plus intravenous gentamicin in both study arms. The monitoring of the patients is carried out according to the WHO protocol for the treatment of severe pneumonia. The primary objective is the rate of treatment failure, defined by the persistence of danger signs of severe pneumonia beyond 48 hours or deterioration within 24 hours of initiation of the therapy. The secondary objectives are (1) improvement in or the resolution of danger signs since enrollment, (2) length of hospital stay, (3) death during hospitalization, and (4) rate of nosocomial infections. Results Enrollment in the study started on January 1, 2018, and ended on October 31, 2019. Data entry and analysis are in progress. Findings from the study are expected to be disseminated in October 2020. Conclusions Our study's findings will improve compliance with the use of antibiotics that require less frequent doses for the treatment of severe pneumonia. Trial Registration ClinicalTrials.gov NCT03369093; https://clinicaltrials.gov/ct2/show/NCT03369093 International Registered Report Identifier (IRRID) DERR1-10.2196/17735

scholarly journals Intravenous Amoxicillin Plus Intravenous Gentamicin for Children with Severe Pneumonia in Bangladesh: An Open-Label, Randomized, Non-Inferiority Controlled Trial

Life ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. 1299
Author(s):  
Lubaba Shahrin ◽  
Mohammod Jobayer Chisti ◽  
Monira Sarmin ◽  
Abu Sayem Mirza Md. Hasibur Rahman ◽  
Abu Sadat Mohammad Sayeem Bin Shahid ◽  
...  
Keyword(s):  
Treatment Failure ◽  
Controlled Trial ◽  
Length Of Hospital Stay ◽  
Severe Pneumonia ◽  
Nursing Intervention ◽  
World Health ◽  
Open Label ◽  
Serious Adverse Events ◽  
Under Five ◽  
Danger Signs

The World Health Organization (WHO) recommends intravenous (IV) ampicillin and gentamicin as first-line therapy to treat severe pneumonia in children under five years of age. Ampicillin needs to be administered at a six-hourly interval, which requires frequent nursing intervention and bed occupancy for 5–7 days, limiting its utility in resource-poor settings. We compared the efficacy of IV amoxicillin over IV ampicillin, which is a potential alternative drug in treating severe pneumonia in children between 2–59 months. We conducted an unblinded, randomized, controlled, non-inferiority trial in the Dhaka hospital of icddr,b from 1 January 2018 to 31 October 2019. Children from 2–59 months of age presenting with WHO defined severe pneumonia with respiratory danger signs were randomly assigned 1:1 to either 50 mg/kg ampicillin or 40 mg/kg amoxicillin per day with 7.5 mg/kg gentamicin. The primary outcome was treatment failure as per the standard definition of persistence of danger sign(s) of severe pneumonia beyond 48 h or deterioration within 24 h of therapy initiation. The secondary outcomes were: (i) time required for resolution of danger signs since enrolment, (ii) length of hospital stay, (iii) death during hospitalization, and (iv) rate of nosocomial infections. Among 308 enrolled participants, baseline characteristics were similar among the two groups. Sixty-two (20%) children ended up with treatment failure, 21 (14%) in amoxicillin, and 41 (27%) in ampicillin arm, which is statistically significant (relative risk [RR] 0.51, 95% CI 0.32–0.82; p = 0.004). We reported 14 deaths for serious adverse events, 4 (3%) and 10 (6%) among amoxicillin and ampicillin arm, respectively. IV amoxicillin and IV gentamicin combination is not inferior to combined IV ampicillin and IV gentamicin in treating severe pneumonia in under-five children in Bangladesh. Considering the less frequent dosing and more compliance, IV amoxicillin is a better choice for treating children with severe pneumonia in resource-limited settings.

scholarly journals 0.9% saline V/S Ringer’s lactate for fluid resuscitation in adult sepsis patients in emergency medical services: An open-label randomized controlled trial

2020 ◽  
pp. 102490792094898
Author(s):  
Rithvik Golla ◽  
Susheel Kumar ◽  
Deba Prasad Dhibhar ◽  
Ashish Bhalla ◽  
Navneet Sharma
Keyword(s):  
Acute Kidney Injury ◽  
Hospital Stay ◽  
Controlled Trial ◽  
Kidney Injury ◽  
Saline Group ◽  
P Value ◽  
Open Label ◽  
Randomized Controlled ◽  
Serum Chloride ◽  
Ringer’S Lactate

Background: 0.9% saline commonly used for resuscitation of septic patients might induce biochemical changes leading to detrimental effects. Ringer’s lactate being a balanced crystalloid might be beneficial in such a scenario. Objectives: We undertook this study to explore in detail the effect of these fluids in the resuscitation of septic patients, and risks and benefits these two fluids would have on the overall prognosis of patients. Methods: This was an open-label randomized controlled trial undertaken in emergency medical services attached to the department of medicine at a tertiary care teaching hospital. One hundred sixty adult (⩾18 years old) medical patients admitted with the diagnosis of sepsis fulfilling eligibility criteria were included. They were randomly assigned to receive 0.9% saline or ringer’s lactate. These fluids were given for the initial 24 h only, and after then, the type of fluid given was based on treating physician discretion. Various biochemical parameters were measured at baseline and various time points during the hospital stay. The primary outcome was to find out the incidence of hyperchloremia at 24 h from the time of randomization and during the hospital stay. The secondary outcomes were incidence of acute kidney injury, need for renal replacement therapy; differences in pH, bicarbonate, serum lactate, coagulation parameters, sequential organ failure assessment scores at various time points; and hospital/30-day mortality. Results: The baseline characteristics in both groups were comparable. At admission, each group had a serum chloride value which was comparable ( p value: 0.595); however, at 24 and 48 h, a statistically significant difference was noticed, with 0.9% saline group having a higher mean serum chloride value (113.66 ± 10.04 v/s 108.98 ± 8.04 mEq/L, p value: 0.001 at 24 h) and (114.75 ± 9.51 v/s 111.12 ± 7.84 mEq/L, p value: 0.022 at 48 h). At 24 and 48 h post-randomization, the incidence of hyperchloremia was significantly higher in the 0.9% saline group (at 24 h, 0.9% saline: 75.0% v/s Ringer’s lactate: 48.8%, p value: 0.001 and at 48 h, 0.9% saline: 77.2% v/s Ringer’s lactate: 60.3%, p value: 0.022), although there was no difference in the incidence of hyperchloremia recorded during the hospital stay. Acute kidney injury incidence at 24 and 48 h post-randomization was significantly higher in the 0.9% saline group (at 24 h, 0.9% saline: 23.8% v/s Ringer’s lactate: 10.0%, p value: 0.020 and at 48 h, 0.9% saline: 29.1% v/s Ringer’s lactate: 15.4%, p value: 0.039). No significant differences in other secondary outcomes were observed. Conclusion: Higher incidence of hyperchloremia and a higher rate of acute kidney injury at 24 and 48 h after randomization were noted in the 0.9% saline group.

scholarly journals Effect of Arbidol (Umifenovir) on COVID-19: a randomized controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Marzieh Nojomi ◽  
Zeynab Yassin ◽  
Hossein Keyvani ◽  
Mahin Jamshidi Makiani ◽  
Maryam Roham ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Oxygen Saturation ◽  
Controlled Trial ◽  
Linear Regression Analysis ◽  
World Health ◽  
Open Label ◽  
Peripheral Oxygen Saturation ◽  
Significance Level ◽  
Randomized Controlled ◽  
Duration Of Hospitalization

Abstract Background Treatment of patients with COVID-19 has included supportive care to mainly relief symptoms of the disease. Although World Health Organization (WHO) has not recommended any effective treatments for COVID-19, there are some reports about use of antiviral drugs. The aim of this study is to determine the effect of Arbidol (ARB) on COVID-19 disease. Methods Using an open-label randomized controlled trial, we examined the efficacy of ARB in patients with COVID-19 in a teaching hospital. One hundred eligible patients with diagnosis of COVID-19 were recruited in the study and assigned randomly to two groups of either hydroxychloroquine followed by KALETRA (Lopinavir/ritonavir) or hydroxychloroquine followed by ARB. The primary outcome was hospitalization duration and clinical improvement 7 days after admission. The criteria of improvement were relief of cough, dyspnea, and fever. Time to relief from fever was also assessed across the two groups. Without any dropouts, 100 patients were entered into the study for the final analysis at significance level of 0.05. Results The mean age of patients was 56.6 (17.8) years and 56.2 (14.8) years in ARB and KALETRA groups, respectively. Majority of patients were male across two groups (66 and 54%). The duration of hospitalization in ARB group was significantly less than KALETRA arm (7.2 versus 9.6 days; P = 0.02). Time to relief fever was almost similar across two groups (2.7 versus 3.1 days in ARB and KALETRA arms, respectively). Peripheral oxygen saturation rate was significantly different after 7 days of admission across two groups (94% versus 92% in ARB and KALETRA groups respectively) (P = 0.02). Based on multiple linear regression analysis, IHD, Na level, and oxygen saturation at the time of admission and type of therapy were the independent adjusted variables that determined the duration of hospitalization in patients with COVID-19. Conclusion Our findings showed that Arbidol, compared to KALETRA, significantly contributes to clinical and laboratory improvements, including peripheral oxygen saturation, requiring ICU admissions, duration of hospitalization, chest CT involvements, WBC, and ESR. We suggest further studies on ARB against COVID-19 using larger sample size and multicenter design. Trial registration IRCT20180725040596N2 on 18 April 2020.

DURATION-8 Randomized Controlled Trial 104-Week Results—Once-Weekly Exenatide (ExQW) plus Once-Daily Dapagliflozin (DAPA) vs. ExQW or DAPA Alone

Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 104-LB ◽  
Author(s):  
SERGE JABBOUR ◽  
CRISTIAN GUJA ◽  
ELISE HARDY ◽  
SUDIPTA BHATTACHARYA ◽  
PETER K. OHMAN ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Once Daily ◽  
Randomized Controlled
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