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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

963 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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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

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Fast Breathing in Young Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Amoxicillin

This is an active intervention

Group Type ACTIVE_COMPARATOR

Amoxicillin

Intervention Type DRUG

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

Sugar Syrup

Group Type PLACEBO_COMPARATOR

Sugar Syrup

Intervention Type DRUG

It will be given 2 times/day for 7 days

Interventions

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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

Intervention Type DRUG

Sugar Syrup

It will be given 2 times/day for 7 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Young infant (0-59 days of age)
* Fast breathing i.e., respiratory rate ≥60 breaths/min
* O2 Saturation ≥90%
* Resident of catchment area (to ensure complaint and follow up)
* Refused hospitalization and investigations
* Informed consent is provided by a parent (or legal guardian).

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

Maximum Eligible Age

59 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No