NCT00513500

Brief Summary

The purpose of the study is to demonstrate the effectiveness and feasibility of community-based management of pneumonia and malaria by community health workers (CHWs) in a rural district of Zambia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,125

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

June 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
11 months until next milestone

Results Posted

Study results publicly available

July 13, 2010

Completed
Last Updated

July 20, 2010

Status Verified

July 1, 2010

Enrollment Period

1.7 years

First QC Date

August 7, 2007

Results QC Date

April 27, 2010

Last Update Submit

July 13, 2010

Conditions

PneumoniaMalaria

Keywords

community health carecommunity health workermalariapneumoniarapid diagnostic test

Outcome Measures

Primary Outcomes (2)

  • Number of Children Who Received Early and Appropriate Treatment for Pneumonia.

    Early and appropriate is defined as receiving 13-15 doses of amoxicillin over 5 days and receiving the first dose within 24-48 hours of onset of first symptom

    one year

  • Number of Children With Fever Who Received Coartem (Artemether-lumefantrine)

    one year

Secondary Outcomes (1)

  • Number of Children Who do Not Respond to Treatment for Pneumonia

    one year

Study Arms (2)

1

EXPERIMENTAL

Give one half tablet (20mg artemether, 120mg lumefantrine) to children weighing (5-9.9kg) and one tablet to children weighing (10-20kg) twice a day for three days for malaria based on rapid diagnostic test. For pneumonia, give one half tablet (250mg amoxicillin) for children weighing (5-9.9kg) and one tablet for children weighing (10-20kg) three times a day for five days.

Drug: Coartem and amoxicillin

2

ACTIVE COMPARATOR

Give one half tablet (20mg artemether, 120mg lumefantrine) to children weighing (5-9.9kg) and one tablet to children weighing (10-20kg) twice a day for three days for malaria based on clinical diagnosis. For pneumonia, refer to the nearest health facility

Drug: Coartem

Interventions

Coartem and amoxicillinDRUG

Perform RDT and give Coartem for malaria and give amoxicillin for fast breathing

1
CoartemDRUG

Give Coartem without RDT and refer fast breathing

2

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age between 6 months and 5 years
  • Present with history of fever or reported fever
  • Present with cough or difficult breathing

You may not qualify if:

  • Age below 6 months and above 5 years
  • Presence of signs and symptoms of severe illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chikankata Health Services

Chikankata, Southern Province, Zambia

Location

Related Publications (1)

  • Yeboah-Antwi K, Pilingana P, Macleod WB, Semrau K, Siazeele K, Kalesha P, Hamainza B, Seidenberg P, Mazimba A, Sabin L, Kamholz K, Thea DM, Hamer DH. Community case management of fever due to malaria and pneumonia in children under five in Zambia: a cluster randomized controlled trial. PLoS Med. 2010 Sep 21;7(9):e1000340. doi: 10.1371/journal.pmed.1000340.

    PMID: 20877714DERIVED

MeSH Terms

Conditions

PneumoniaMalaria

Interventions

Artemether, Lumefantrine Drug CombinationAmoxicillin

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesProtozoan InfectionsParasitic DiseasesMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ArtemetherArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsLumefantrineFluorenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSesquiterpenesTerpenesPolycyclic CompoundsDrug CombinationsPharmaceutical PreparationsAmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Limitations and Caveats

Imbalance in enrollment. More patients enrolled in the control arm possibly due to many control community health workers working full time and available to see patients all day.

Results Point of Contact

Title
Kojo Yeboah-Antwi
Organization
Boston University
kyantwi@bu.edu
617-414-1275

Study Officials

  • Kojo Yeboah-Antwi, MD, MPH

    Center for International Health and Development

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 7, 2007

First Posted

August 8, 2007

Study Start

June 1, 2007

Primary Completion

February 1, 2009

Study Completion

September 1, 2009

Last Updated

July 20, 2010

Results First Posted

July 13, 2010

Record last verified: 2010-07

Locations

ZA(1)