Trial of Amoxicillin Compared With Placebo for Pneumonia in Children Aged 2-59 Months

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Many children with "non-severe pneumonia" (cough and fast breathing) have neither clinical pneumonia as assessed by physicians nor pneumonia on chest radiographs. Inappropriate use of antibiotics for these cases is leading to resistant strains of bacteria in the community. Evidence shows that almost 50% of antibiotic prescription is unnecessary.As over half of antibiotic prescription for ARI are not necessary since most of these infections are viral and do not respond to antibiotic therapy which will be source of resistance in the community.

To address this issue the investigators conducted this randomized, double blind placebo controlled clinical trial of oral Amoxicillin versus placebo in children with non-severe pneumonia taking into account all the necessary safety precautions for their well being.

The study hypothesis was that the clinical outcome of children 2 to 59 months of age with cough and fast breathing (WHO defined non-severe pneumonia) with or without wheezing is equivalent, whether they are treated with amoxicillin or placebo.

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

Details

• Lead Sponsor: Pakistan Institute of Medical Sciences
• Collaborator: World Health Organization
• Treatments: Amoxicillin

Criteria

Inclusion Criteria:

• Children aged 2 to 59 months attending the outpatient's clinics of participating sites

• WHO defined non-severe pneumonia

• Accessibility for follow-up

• Written informed consent by a parent or legal guardian

Exclusion Criteria:

• WHO signs of severe pneumonia recognised by lower chest wall retraction. Children who present with wheezing will be evaluated for lower chest wall indrawing after treatments with nebulised salbutamol. WHO signs of very severe disease/pneumonia defined as any of the following:

1. Cyanosis

2. Inability to drink

3. Convulsions

4. Abnormally sleepy or difficult to wake

• Severe malnutrition recognised by weight for age less than third percentile by the NCHS (National Child Health Statistics) growth chart and/or oedema (see chart).

• All patients with a previous history of 3 or more episodes of wheeze or diagnosed to have asthma.

• Known or clinically recognisable congenital heart disease with cyanosis or, congestive heart failure or cardiomegaly.

• Known or clinically recognisable acute/chronic organ system disorders including jaundice, nephrotic syndrome, severe anaemia manifested as extreme pallor etc.

• Other infectious conditions requiring antibiotic therapy at the day of contact including meningitis, tuberculosis, dysentery, osteomyelitis, septic arthritis etc.

• Children who have taken the appropriate doses of WHO-recommended dose of anti microbial drug for 48 hours prior to presentation.

• A history of hospitalization in the past 2 weeks

• Measles or a history of measles within the last month: Measles recognized by presence of fever with rash, and conjunctivitis.

• Prior enrolment in the current trial.

• Known penicillin allergy, including a history of rash, urticaria, or anaphylactic symptoms.

• The children living outside the municipal limits of the city who cannot be followed up.