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

Primary Purpose

Fast Breathing in Young Infants

Status
Terminated
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Amoxicillin
Sugar Syrup
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fast Breathing in Young Infants focused on measuring Fast breathing, Young infants, Management, Amoxicillin, Placebo

Eligibility Criteria

undefined - 59 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Primary Health Centers

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Amoxicillin

Sugar Syrup

Arm Description

This is an active intervention

Outcomes

Primary Outcome Measures

Treatment failure
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

Secondary Outcome Measures

Compliance to treatment
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

Full Information

First Posted
February 13, 2012
Last Updated
June 2, 2014
Sponsor
Aga Khan University
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1. Study Identification

Unique Protocol Identification Number
NCT01533818
Brief Title
Community Based Management of Fast Breathing in Infants Aged < 60 Days in Low-income Settlements of Karachi
Acronym
MAT-YI
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

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped by DSMB based on high treatment failure rate in placebo compared to active drug.
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fast Breathing in Young Infants
Keywords
Fast breathing, Young infants, Management, Amoxicillin, Placebo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
963 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amoxicillin
Arm Type
Active Comparator
Arm Description
This is an active intervention
Arm Title
Sugar Syrup
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Sugar Syrup
Intervention Description
It will be given 2 times/day for 7 days
Primary Outcome Measure Information:
Title
Treatment failure
Description
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
Time Frame
Day 8 of enrollemnt
Secondary Outcome Measure Information:
Title
Compliance to treatment
Description
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.
Time Frame
80% of total dosage
Title
Proportion of infants relapse
Time Frame
No treatment failure by day 8 and signs of sepsis or fast breathing between day 8-14

10. Eligibility

Sex
All
Maximum Age & Unit of Time
59 Days
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiyam Sunder P Tikmani, MBBS
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary Health Centers
City
Karachi
State/Province
Sind
ZIP/Postal Code
74800
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
27941119
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.
Results Reference
derived
Links:
URL
http://www.aku.edu
Description
Related Info

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

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