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

Phase 4

Terminated

• Conditions: Fast Breathing in Young Infants
• Interventions: Drug: Amoxicillin; Drug: Sugar Syrup

• Registration Number: NCT01533818
• Lead Sponsor: Aga Khan University

Brief 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.

Study Timeline

• Study First Submitted: 2012-02-13
• Study First Submitted QC: 2012-02-14
• Study First Posted: 2012-02-15
• Study Start: 2012-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-02
• Last Update Posted: 2014-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 963

Inclusion Criteria

Not provided

Exclusion Criteria

• Preterm infants (born <37 weeks)
• Presence of audible murmur
• Any concurrent signs of severe infection:
• not feeding well
• movement only when stimulated
• severe chest in-drawing
• axillary temperature ≥38.0oC or ≤35.5oC
• Any sign of being critically ill (Cyanosis, bulging fontanel, unable to feed, unable to cry, apnoea, convulsions, unconscious, persistent vomiting)
• Weight <1800gm at the time of presentation
• Major congenital malformations or suspected chromosomal abnormalities
• Hospitalization for illness in the last two weeks
• Previous inclusion in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Amoxicillin	Amoxicillin	This is an active intervention
Sugar Syrup	Sugar Syrup	-

Primary Outcome Measures

Name	Time	Method
Treatment failure	Day 8 of enrollemnt	1. O2 sat \<90% on Day 2 or any time until Day 7.; 2. Clinical deterioration: emergence of any sign of being critically ill or severe infection at any time after randomization (as defined in exclusion criteria); 3. Development of serious adverse effect of the study antibiotics (death, organ failure, anaphylactic reaction, severe diarrhoea, disseminated and severe rash).; 4. Hospitalization any time after admission in the study.; 5. Death anytime within day 1-7 of enrolment

Secondary Outcome Measures

Name	Time	Method
Compliance to treatment	80% of total dosage	To label as per protocol infant should receive 100% (4 doses) of doses in first 2 days followed by 70% (7 doses) of doses from day 3 to day 8.
Proportion of infants relapse	No treatment failure by day 8 and signs of sepsis or fast breathing between day 8-14

Trial Locations

Locations (1)

Primary Health Centers; 🇵🇰 Karachi, Sind, Pakistan