Double-blind Randomized Controlled Clinical Trial of 3 Days of Amoxicillin Disperable Tablet (DT) Versus Placebo for Fast Breathing Childhood Pneumonia Among Children 2-59 Months of Age Presenting to Kamuzu Central Hospital in Lilongwe, Malawi

Save the Children2 sites in 1 country1,126 target enrollmentJune 2016

ConditionsPneumonia

InterventionsPlacebo Amoxicillin

DrugsAmoxicillin Placebo

Overview

Phase: Phase 4
Intervention: Placebo
Conditions: Pneumonia
Sponsor: Save the Children
Enrollment: 1126
Locations: 2
Primary Endpoint: Proportion of children failing treatment
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study to assess the effectiveness of no antibiotic treatment for fast breathing, community-acquired childhood pneumonia in a malaria-endemic region of Malawi.

Registry

clinicaltrials.gov

Start Date

June 2016

End Date

June 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Save the Children

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•History of cough \<14 days or difficult breathing with fast breathing (for children 2 to \<12 months of age, \>50 breaths/minute and for children \>12 months of age, \> 40 breaths/minute).
•Ability and willingness of children's caregiver to provide informed consent and to be available for follow-up for the planned duration of the study, including accepting a home visit if he/she fails to return to Kamuzu Central Hospital (KCH) with the child for a scheduled study follow-up visit.

Exclusion Criteria

•If fast breathing observed at screening resolves after bronchodilator challenge.
•Chest-indrawing.
•Severe respiratory distress, classified by World Health Organization (WHO) pocketbook guidelines (e.g., grunting, nasal flaring, head nodding, crackles on auscultation, or very severe chest-indrawing).
•Presence of WHO Intergrated Management of Childhood Illness (IMCI) danger signs including: lethargy or unconsciousness, convulsions, vomiting everything, or inability to drink or breastfeed.
•Hypoxia (SaO2 \< 90% on room air, as assessed by a Lifebox pulse oximeter).
•Stridor when calm.
•HIV-1 seropositivity or HIV-1 exposure, assessed as follows:
•An HIV-positive result upon rapid antibody test will exclude any child from this study. If a child is less than 12 months or age or breastfeeding with a positive rapid test result, the child will be referred to receive additional confirmatory HIV testing (e.g., dried blood spot filter paper test) and follow-up from KCH staff, as per standard of care. Even if the confirmatory HIV testing subsequently shows that child is HIV-negative, he or she will remain excluded from the study.
•If a child is less than 12 months of age or breastfeeding and has an HIV-negative result upon rapid antibody test, the child's biological mother's HIV status will need to be assessed. If the mother is HIV-positive, the child will be excluded. If the mother has a documented HIV-negative test result from within the past 3 months, the child will be included. If the mother does not have documentation of an HIV-negative test result, she will be tested via rapid antibody testing to determine the child's eligibility for this study.
•If a child is over 12 months of age and not breastfeeding, an HIV-negative rapid antibody test is required for inclusion in the study.

Arms & Interventions

Placebo

250 mg of placebo (dispersible tablet) DT in two divided doses based on age bands (500 mg/day for children 2 months up to 12 months, 1000 mg/day for children 12 months up to 3 years, and 1,500 mg/day for children 3 years up to 5 years of age)

Intervention: Placebo

3 Days

250 mg amoxicillin (dispersible tablet) DT in two divided doses based on age bands (500 mg/day for children 2 months up to 12 months, 1000 mg/day for children 12 months up to 3 years, and 1,500 mg/day for children 3 years up to 5 years of age)

Intervention: Amoxicillin