Clinical trial NCT01533818: Community Based Management of Fast Breathing in Infants Aged < 60 Days in Low-income Settlements of Karachi
Official title: Community Based Management of Fast Breathing in Infants Aged < 60 Days: A Double-Blind, Randomized Placebo-Controlled Trial in Low-income Settlements of Karachi
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Fast Breathing in Young Infants
Keywords: Fast breathing
Young infants
Management
Amoxicillin
Placebo
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2012-02-15
Enrollment: 963
Sex: ALL
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment failure
timeFrame: Day 8 of enrollemnt
Secondary outcomes:
measure: Compliance to treatment
timeFrame: 80% of total dosage
measure: Proportion of infants relapse
timeFrame: No treatment failure by day 8 and signs of sepsis or fast breathing between day 8-14
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Primary Health Centers
state: Sind
Study officials:
affiliation: Aga Khan University
name: Shiyam Sunder P Tikmani, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tikmani SS, Muhammad AA, Shafiq Y, Shah S, Kumar N, Ahmed I, Azam I, Pasha O, Zaidi AK. Ambulatory Treatment of Fast Breathing in Young Infants Aged <60 Days: A Double-Blind, Randomized, Placebo-Controlled Equivalence Trial in Low-Income Settlements of Karachi. Clin Infect Dis. 2017 Jan 15;64(2):184-189. doi: 10.1093/cid/ciw690. Epub 2016 Oct 19.