NCT01533818

Community Based Management of Fast Breathing in Infants Aged < 60 Days in Low-income Settlements of Karachi

Community Based Management of Fast Breathing in Infants Aged < 60 Days: A Double-Blind, Randomized Placebo-Controlled Trial in Low-income Settlements of Karachi

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 963 (actual)
• Sponsor: Aga Khan University · Academic / Other
• Sex: All
• Age: 59 Days
• Healthy volunteers: Not accepted

Summary

The aim of the study is to determine optimal management of isolated fast breathing in young infants in a trial design conducted in primary care settings. The investigators hypothesized that proportion of infants who fail therapy will be 4% in each group. A 6% or less difference in failure rate will be considered equivalent.

Detailed description

The management of isolated fast breathing is therefore unknown and our experience suggests that these infants could perhaps be managed without antibiotics. Widespread application of the WHO clinical algorithm could therefore result in the referral of as many as 13.7% (135.7 per 1000 live births) of all infants for isolated fast breathing, the vast majority of these unnecessarily, and exposing infants to a high risk of nosocomial sepsis and hospital mortality in addition to over-burdening health resources.

Conditions

• Fast Breathing in Young Infants

Interventions

Type	Name	Description
DRUG	Amoxicillin	80-100 mg/kg/day in 2 divided doses for 7 days For convenience dose divided into six weight bands Table 2: Dose of amoxicillin Weight band Amount per dose Daily dose Lower Limit (mg or units /kg/d) Upper Limit (mg or units /kg/d) Amoxicillin - desired range 75-100 mg/kg/day (25mg/ml (125mg/5ml); twice daily orally)\* 1.8-1.9 kg 3.0 ml 150 mg 75.4 100.0 2.0-2.4 kg 4.0 ml 200 mg 80.3 100.0 2.5-2.9 kg 5.0 ml 250 mg 83.6 100.0 3.0-3.9 kg 6.0 ml 300 mg 75.2 100.0 4.0-4.9 kg 8.0 ml 400 mg 80.2 100.0 5.0-5.9 kg 10.0 ml 500 mg 83.5 100.0
DRUG	Sugar Syrup	It will be given 2 times/day for 7 days

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2012-02-15
• Last updated: 2014-06-03

Locations

1 site across 1 country: Pakistan