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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01533818
Recruitment Status : Terminated (The study was stopped by DSMB based on high treatment failure rate in placebo compared to active drug.)
First Posted : February 15, 2012
Last Update Posted : June 3, 2014
Information provided by (Responsible Party):
Shiyam Sunder Tikmani, Aga Khan University

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.

Condition or disease Intervention/treatment Phase
Fast Breathing in Young Infants Drug: Amoxicillin Drug: Sugar Syrup Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 963 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : May 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Treatment failure [ Time Frame: Day 8 of enrollemnt ]
    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 :
  1. Compliance to treatment [ Time Frame: 80% of total dosage ]
    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.

  2. Proportion of infants relapse [ Time Frame: No treatment failure by day 8 and signs of sepsis or fast breathing between day 8-14 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 59 Days   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01533818

Primary Health Centers
Karachi, Sind, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Principal Investigator: Shiyam Sunder P Tikmani, MBBS Aga Khan University

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Shiyam Sunder Tikmani, Research Supervisor, Aga Khan University Identifier: NCT01533818     History of Changes
Other Study ID Numbers: 1979-CHS-ERC-11
First Posted: February 15, 2012    Key Record Dates
Last Update Posted: June 3, 2014
Last Verified: June 2014

Keywords provided by Shiyam Sunder Tikmani, Aga Khan University:
Fast breathing
Young infants

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents