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

This study has been terminated.
(The study was stopped by DSMB based on high treatment failure rate in placebo compared to active drug.)
Sponsor:
Information provided by (Responsible Party):
Shiyam Sunder Tikmani, Aga Khan University
ClinicalTrials.gov Identifier:
NCT01533818
First received: February 13, 2012
Last updated: June 2, 2014
Last verified: June 2014
  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: Bio-equivalence 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

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Treatment failure [ Time Frame: Day 8 of enrollemnt ] [ Designated as safety issue: Yes ]
    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:
  • 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 ]

Enrollment: 963
Study Start Date: May 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01533818

Locations
Pakistan
Primary Health Centers
Karachi, Sind, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Investigators
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: June 2, 2014
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
Pathologic Processes
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014