دورية أكاديمية
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
| العنوان: | 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 |
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| المؤلفون: | Shahrin, Lubaba, Chisti, Mohammod Jobayer, Shahid, Abu Sadat Mohammad Sayeem Bin, Rahman, Abu Sayem Mirza Mohammad Hasibur, Islam, Md. Zahidul, Afroze, Farzana, Huq, Sayeeda, Ahmed, Tahmeed |
| المصدر: | JMIR Research Protocols, Vol 9, Iss 11, p e17735 (2020) |
| بيانات النشر: | JMIR Publications, 2020. |
| سنة النشر: | 2020 |
| المجموعة: | LCC:Medicine LCC:Computer applications to medicine. Medical informatics |
| مصطلحات موضوعية: | Medicine, Computer applications to medicine. Medical informatics, R858-859.7 |
| الوصف: | BackgroundPneumonia 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. ObjectiveThe 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. MethodsThis 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. ResultsEnrollment 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. ConclusionsOur study's findings will improve compliance with the use of antibiotics that require less frequent doses for the treatment of severe pneumonia. Trial RegistrationClinicalTrials.gov NCT03369093; https://clinicaltrials.gov/ct2/show/NCT03369093Test International Registered Report Identifier (IRRID)DERR1-10.2196/17735 |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 1929-0748 |
| العلاقة: | https://www.researchprotocols.org/2020/11/e17735Test; https://doaj.org/toc/1929-0748Test |
| DOI: | 10.2196/17735 |
| الوصول الحر: | https://doaj.org/article/70c5d63b93fc4ff9ad1135aa2c5e16b0Test |
| رقم الانضمام: | edsdoj.70c5d63b93fc4ff9ad1135aa2c5e16b0 |
| قاعدة البيانات: | Directory of Open Access Journals |
Full Text Finder | تدمد: | 19290748 |
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| DOI: | 10.2196/17735 |