Community Based Management of Fast Breathing in Infants Aged < 60 Days in Low-income Settlements of Karachi (MAT-YI)
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.
Fast Breathing in Young Infants
Drug: Sugar Syrup
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Treatment failure [ Time Frame: Day 8 of enrollemnt ] [ Designated as safety issue: Yes ]
- O2 sat <90% on Day 2 or any time until Day 7.
- Clinical deterioration: emergence of any sign of being critically ill or severe infection at any time after randomization (as defined in exclusion criteria)
- Development of serious adverse effect of the study antibiotics (death, organ failure, anaphylactic reaction, severe diarrhoea, disseminated and severe rash).
- Hospitalization any time after admission in the study.
- Death anytime within day 1-7 of enrolment
- Compliance to treatment [ Time Frame: 80% of total dosage ] [ Designated as safety issue: Yes ]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 [ Time Frame: No treatment failure by day 8 and signs of sepsis or fast breathing between day 8-14 ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Amoxicillin
This is an active intervention
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
|Placebo Comparator: Sugar Syrup||
Drug: Sugar Syrup
It will be given 2 times/day for 7 days
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.
|Contact: Shiyam Sunder P Tikmani, MBBS||+9221 3486 4955 ext firstname.lastname@example.org|
|Contact: Mir MAAK Khan, MBA,MPhil||+92 213 493 0051 ext email@example.com|
|Primary Health Centers||Recruiting|
|Karachi, Sind, Pakistan, 74800|
|Contact: Benazir Baloch, MBBS +0221 34982768 firstname.lastname@example.org|
|Contact: Amber Ali Muhammad, MSc +0221 34982768 email@example.com|
|Principal Investigator: Shiyam Sunder P Tikmani, MBBS|
|Sub-Investigator: Anita KM Zaidi, MBBS, SM, FAAP|
|Sub-Investigator: Omrana Pasha, MBBS, DABP|
|Sub-Investigator: Zohra Lassi, BSn, MSc|
|Principal Investigator:||Shiyam Sunder P Tikmani, MBBS||Aga Khan University|