Status:
COMPLETED
Trial of Amoxicillin Compared With Placebo for Pneumonia in Children Aged 2-59 Months
Lead Sponsor:
Pakistan Institute of Medical Sciences
Collaborating Sponsors:
World Health Organization
Conditions:
Acute Respiratory Infections
Pneumonia
Eligibility:
All Genders
2-59 years
Phase:
NA
Brief 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 ...
Detailed Description
Pneumonia is one of the major cause of childhood morbidity and mortality in developing countries. Burden of acute respiratory infections (ARI) is high with an estimated 5-7 episodes in under 5 populat...
Eligibility Criteria
Inclusion
- 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
- 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:
- Cyanosis
- Inability to drink
- Convulsions
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT00851487
Start Date
January 1 2006
End Date
April 1 2008
Last Update
February 26 2009
Active Locations (1)
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1
ARI Research Cell, Children Hospital, PIMS
Islamabad, Federal Capital, Pakistan, 44000