NCT02678195

Brief Summary

This clinical trial evaluates the duration of treatment of chest-indrawing pneumonia in children. Half the children will receive 3 days of amoxicillin dispersible tablets (DT) and then 2 days of placebo, while the other half will receive 5 days of amoxicillin DT.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2016

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
21 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

3.1 years

First QC Date

February 3, 2016

Last Update Submit

February 17, 2021

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Proportion of children failing treatment

    6 days

Study Arms (2)

3 days amoxicillin + 2 days placebo

EXPERIMENTAL

3 days amoxicillin DT + 2 days placebo DT in two divided doses based on age bands (500 mg/day for children 2 months up to 12 months, 1000 mg/day for children 12 months up to 3 years, and 1,500 mg/day for children 3 years up to 5 years of age).

Drug: AmoxicillinDrug: Placebo

5 days amoxicillin

ACTIVE COMPARATOR

5 days amoxicillin DT in two divided doses based on age bands (500 mg/day for children 2 months up to 12 months, 1000 mg/day for children 12 months up to 3 years, and 1,500 mg/day for children 3 years up to 5 years of age).

Drug: Amoxicillin

Interventions

AmoxicillinDRUG

Oral amoxicillin dispersible tablets (DT), 250 mg tablets, given according to age band, two times daily

3 days amoxicillin + 2 days placebo5 days amoxicillin
PlaceboDRUG

Placebo dispersible tablets (DT), 250 mg tablets, given according to age band, two times daily

3 days amoxicillin + 2 days placebo

Eligibility Criteria

Age2 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male or female, 2 to 59 months of age.
  • History of cough \<14 days or difficult breathing with chest-indrawing.
  • Ability and willingness of child's caregiver to provide informed consent and to be available for follow-up for the planned duration of the study, including accepting a home visit if he/she fails to return to Kamuzu Central Hospital (KCH) for a scheduled study follow-up visit.

You may not qualify if:

  • If chest-indrawing observed at screening resolves after bronchodilator challenge, among those with wheeze at screening.
  • Severe respiratory distress (e.g., grunting, nasal flaring, head nodding, or severe chest-indrawing).
  • Presence of World Health Organization (WHO) Integrated Management of Childhood Illness (IMCI) danger signs including: lethargy or unconsciousness, convulsions, vomiting everything, or inability to drink or breastfeed.
  • Hypoxia (SaO2 \< 90% on room air, as assessed by a Lifebox pulse oximeter).
  • Stridor when calm.
  • HIV-1 seropositivity or HIV-1 exposure, assessed as follows:
  • An HIV-positive result upon rapid antibody test will exclude any child from this study.
  • If a child is less than 12 months or age with a positive rapid test result, the child will be referred to receive additional confirmatory HIV testing (e.g., dried blood spot filter paper test) and follow-up from KCH staff, as per standard of care. Even if the confirmatory HIV testing subsequently shows that child is HIV-negative, he or she will remain excluded from the study.
  • If a child is less than 24 months of age and has an HIV-negative result upon rapid antibody test, the child's biological mother's HIV status will need to be assessed. If the mother is HIV-positive, the child will be excluded. If the mother has a documented HIV-negative test result from within the past 6 weeks, the child will be included. If the mother does not have documentation of an HIV-negative test result, she will be tested via rapid antibody testing to determine the child's eligibility for this study.
  • Note: If a child has documentation of an HIV-negative test result from within the past 6 weeks, that test result will be used for the child's eligibility assessment according to the algorithm described above.
  • Severe acute malnutrition (i.e., weight for height/length \< -3 SD, mid-upper arm circumference \<115 mm, or edema).
  • Possible tuberculosis (coughing for more than 14 days).
  • Severe anemia, classified by WHO pocketbook guidelines (i.e., severe palmar pallor or hemoglobin \<8.0 g/dL)
  • Severe malaria, classified by WHO pocketbook guidelines (e.g., positive malaria rapid diagnostic test (mRDT) with any danger sign, stiff neck, abnormal bleeding, clinical jaundice, or hemoglobinuria)
  • Known allergy to penicillin or amoxicillin.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bwaila District Hospital

Lilongwe, Malawi

Location

Kamuzu Central Hospital

Lilongwe, Malawi

Location

Related Publications (4)

  • Ginsburg AS, May S. Analysis of serious adverse events in a pediatric community-acquired pneumonia randomized clinical trial in Malawi. Sci Rep. 2022 Mar 3;12(1):3538. doi: 10.1038/s41598-022-07582-w.

    PMID: 35241775DERIVED

  • Mvalo T, McCollum ED, Fitzgerald E, Kamthunzi P, Schmicker RH, May S, Phiri M, Chirombo C, Phiri A, Ginsburg AS. Chest radiography in children aged 2-59 months enrolled in the Innovative Treatments in Pneumonia (ITIP) project in Lilongwe Malawi: a secondary analysis. BMC Pediatr. 2022 Jan 10;22(1):31. doi: 10.1186/s12887-021-03091-3.

    PMID: 35012490DERIVED

  • Ginsburg AS, Mvalo T, Nkwopara E, McCollum ED, Phiri M, Schmicker R, Hwang J, Ndamala CB, Phiri A, Lufesi N, May S. Amoxicillin for 3 or 5 Days for Chest-Indrawing Pneumonia in Malawian Children. N Engl J Med. 2020 Jul 2;383(1):13-23. doi: 10.1056/NEJMoa1912400.

    PMID: 32609979DERIVED

  • Ginsburg AS, May SJ, Nkwopara E, Ambler G, McCollum ED, Mvalo T, Phiri A, Lufesi N, Sadruddin S. Methods for conducting a double-blind randomized controlled clinical trial of three days versus five days of amoxicillin dispersible tablets for chest indrawing childhood pneumonia among children two to 59 months of age in Lilongwe, Malawi: a study protocol. BMC Infect Dis. 2018 Sep 21;18(1):476. doi: 10.1186/s12879-018-3379-z.

    PMID: 30241517DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Amy Ginsburg, MD, MPH

    Save the Children

    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
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 9, 2016

Study Start

March 1, 2016

Primary Completion

April 1, 2019

Study Completion

December 1, 2019

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations

MA(2)