Randomized Trial of Amoxicillin Versus Placebo for (Fast Breathing) Pneumonia

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The relative benefits and risks of antibiotic therapy in WHO defined fast breathing pneumonia in pre-school children in resource limited settings are controversial both at an individual and public health level. Most infections are viral or self-limiting and non-selective drug treatment has contributed to the global epidemic of antibiotic resistance. There is no high quality trial evidence in managing children with fast breathing in community settings and the WHO itself has called for evidence on which to update guidance. The investigators proposed non inferiority trial comparing standard antibiotic treatment with placebo in poor urban slum settings in South Asia to address this deficit.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aga Khan University
• Treatments: Amoxicillin

Criteria

Inclusion Criteria:

• History of cough or difficult breathing < 14 days (observed or reported) AND

• Respiratory rate ≥ 50 breaths per minute in children 2 to <12 months (on two consecutive readings by independent physicians) OR respiratory rate ≥ 40 breaths per minute in children12- 59 months (on two consecutive readings by independent physicians) AND

• Written informed consent by a legal guardian

Exclusion Criteria:

• Previously enrolled in study

• Pedal edema

• History of hospitalization in last two weeks

• With severe lower chest wall in-drawing

• Known asthmatics,TB or other severe illness

• Antibiotics taken in last 48 hours

• Bulging fontanel

• Congenital heart disease

• Any surgical condition requiring hospitalization

• Out of catchment area

• Any general danger sign as defined by WHO: Stridor when calm; hypoxia (SaO2 < 90% in air) ; inability to feed; persistent vomiting (after three attempts to feed the baby within ½ hour); convulsions; reduced conscious level