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RCT of Efficacy of Amoxicillin Over Ampicillin on Severe Pneumonia

NCT03369093 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2021-07-16

No results posted yet for this study

Summary

Burden: Pneumonia remains the leading infectious cause of death accounting for 920,000 children under five around the world. This means a loss of over 2,500 child lives every day, or over 100 every hour. Since 2000, the number of child deaths caused by pneumonia has decreased by 47 percent. The tremendous progress made is due in part to the rapid roll-out of vaccines, better nutrition, and improved care-seeking and treatment for symptoms. However, pneumonia hasn't declined as quickly as other diseases such as malaria (58%), HIV/AIDS (61%), and measles (85%).

Knowledge gap: The Lancet Series on Childhood Pneumonia and Diarrhea has reported that case management is one of the three most effective interventions to reduce pneumonia deaths in children. It is also noted that the cost-effectiveness of these interventions in the national health system needs urgent assessment. It was suggested to find out means to reduce hospital stay without compromising the quality of care.

Relevance: The main purpose of the study is to compare the efficacy of two doses of parenteral Amoxicillin plus single-dose Gentamicin compared to four doses of parenteral Ampicillin plus single-dose Gentamicin. After 72 hours of treatment injectable Amoxicillin or injection Ampicillin will be switched to or replaced by oral Amoxicillin and will be discharged with an advice to attend to Ambulatory Care Unit (ACU) to receive a once-daily dose of injection Gentamicin for a total of 5 days. It is anticipated that this modified therapy will reduce the hospitalization stay of children with severe pneumonia and would therefore be relevant in countries with the resource-poor settings. By reducing the hospitalization period, this therapy has the potentials to reduce hospital-acquired infection.

Hypothesis (if any): Rate of treatment failure with two doses of injectable Amoxicillin plus single-dose Gentamicin will be no more than that of four doses of injectable Ampicillin plus single-dose Gentamicin in the management of children between 2 months to 59 months hospitalized for WHO classified severe pneumonia.

Conditions

  • Treatment Failure
  • Lethargy
  • Altered Mental Status
  • Convulsion, Non-Epileptic
  • Hypoxia
  • Feeding; Difficult, Newborn

Interventions

DRUG

Amoxicillin

Twice daily doses of injectable amoxicillin

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Principal Investigators

  • Lubaba Shahrin, MBBS, FCPS · Dhaka Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2019-10-31
Completion
2019-12-31

Countries

  • Bangladesh

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03369093 on ClinicalTrials.gov