Community Based Management of Fast Breathing in Infants Aged < 60 Days in Low-income Settlements of Karachi (MAT-YI)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fast Breathing in Young Infants |
Drug: Amoxicillin Drug: Sugar Syrup |
Phase 4 |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 500 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Amoxicillin
This is an active intervention
|
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 |
| Placebo Comparator: Sugar Syrup |
Drug: Sugar Syrup
It will be given 2 times/day for 7 days
|
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| Ages Eligible for Study: | up to 59 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Shiyam Sunder P Tikmani, MBBS | +9221 3486 4955 ext 4955 | shiyam.sunder@aku.edu |
| Contact: Mir MAAK Khan, MBA,MPhil | +92 213 493 0051 ext 4385 | asghar.ali@aku.edu |
| Pakistan | |
| Primary Health Centers | Recruiting |
| Karachi, Sind, Pakistan, 74800 | |
| Contact: Benazir Baloch, MBBS +0221 34982768 benazir.balouch@aku.edu | |
| Contact: Amber Ali Muhammad, MSc +0221 34982768 amber.rajpari@gmail.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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Shiyam Sunder Tikmani, Research Supervisor, Aga Khan University |
| ClinicalTrials.gov Identifier: | NCT01533818 History of Changes |
| Other Study ID Numbers: | 1979-CHS-ERC-11 |
| Study First Received: | February 13, 2012 |
| Last Updated: | February 14, 2013 |
| Health Authority: | Pakistan: Aga Khan University |
Keywords provided by Aga Khan University:
|
Fast breathing Young infants Management Amoxicillin Placebo |
Additional relevant MeSH terms:
|
Respiratory Aspiration Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
Amoxicillin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013