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

NCT01533818 | Terminated Phase 4 DMC

• 1 other identifier: 1979-CHS-ERC-11
• Study Type: interventional
• Target: 963
• Locations: 1 country
• Sites: 1

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.

Conditions

Fast Breathing in Young Infants

Keywords

Fast breathing; Young infants; Management; Amoxicillin; Placebo

Outcome Measures

Primary Outcomes (1)

• Treatment failure

  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

  Day 8 of enrollemnt

Secondary Outcomes (2)

• Compliance to treatment

  80% of total dosage

• Proportion of infants relapse

  No treatment failure by day 8 and signs of sepsis or fast breathing between day 8-14

Study Arms (2)

Amoxicillin

ACTIVE COMPARATOR

This is an active intervention

Drug: Amoxicillin

Sugar Syrup

PLACEBO COMPARATOR

Drug: Sugar Syrup

Interventions

Amoxicillin DRUG

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

Amoxicillin

Sugar Syrup DRUG

It will be given 2 times/day for 7 days

Sugar Syrup

Eligibility Criteria

• Age: Up to 59 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Primary Health Centers

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 27941119 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Hyperventilation

Interventions

Amoxicillin; High Fructose Corn Syrup

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dietary Sugars; Dietary Carbohydrates; Carbohydrates; Sugars; Nutritive Sweeteners; Sweetening Agents; Flavoring Agents; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Shiyam Sunder P Tikmani, MBBS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Supervisor

Study Record Dates

• First Submitted: February 13, 2012
• First Posted: February 15, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 3, 2014

Record last verified: 2014-06

Locations

PA (1)