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Zambia Integrated Management of Malaria and Pneumonia Study (ZIMMAPS)

Primary Purpose

Pneumonia, Malaria

Status
Completed
Phase
Not Applicable
Locations
Zambia
Study Type
Interventional
Intervention
Coartem and amoxicillin
Coartem
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pneumonia focused on measuring community health care, community health worker, malaria, pneumonia, rapid diagnostic test

Eligibility Criteria

6 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Chikankata Health Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Children Who do Not Respond to Treatment for Pneumonia

Full Information

First Posted
August 7, 2007
Last Updated
July 13, 2010
Sponsor
Boston University
Collaborators
Center for International Health and Development, United States Agency for International Development (USAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00513500
Brief Title
Zambia Integrated Management of Malaria and Pneumonia Study
Acronym
ZIMMAPS
Official Title
Zambia Integrated Management of Malaria and Pneumonia Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Boston University
Collaborators
Center for International Health and Development, United States Agency for International Development (USAID)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Pneumonia and malaria are the two leading causes of morbidity and mortality among children under five in sub-Saharan Africa. Due to limited access to health services in many developing countries, a number of global health organizations, including the World Health Organization, have strongly advocated the use of community health workers (CHWs) to deliver basic health care in the community and to facilitate referral to primary health facilities. Existing supported CHWs in the study area will be trained in the assessment and classification of children between six months and five years of age presenting with fever and/or cough/difficult breathing. In the intervention arm, CHWs will be supplied with rapid diagnostic tests (RDTs), Coartem (a fixed dose combination of artemether-lumefantrine) and amoxicillin. The intervention CHWs will be trained to use RDTs in patients with reported fever and provide those with a positive result with Coartem; and patients suspected of pneumonia (based on fast breathing) will be treated with amoxicillin as per the standard of care at health facilities and monitored. In the control arm, no RDT will be performed. The CHWs will be supplied with Coartem to treat malaria/febrile illness as per the integrated management of childhood illnesses (IMCI) guidelines and patients suspected of pneumonia will be referred to the health facility for treatment as per the current practice. Data collectors will routinely visit CHWs to collect data on their consultations and follow-up patients treated by CHWs in their homes..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Malaria
Keywords
community health care, community health worker, malaria, pneumonia, rapid diagnostic test

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Coartem and amoxicillin
Intervention Description
Perform RDT and give Coartem for malaria and give amoxicillin for fast breathing
Intervention Type
Drug
Intervention Name(s)
Coartem
Intervention Description
Give Coartem without RDT and refer fast breathing
Primary Outcome Measure Information:
Title
Number of Children Who Received Early and Appropriate Treatment for Pneumonia.
Description
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
Time Frame
one year
Title
Number of Children With Fever Who Received Coartem (Artemether-lumefantrine)
Time Frame
one year
Secondary Outcome Measure Information:
Title
Number of Children Who do Not Respond to Treatment for Pneumonia
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 6 months and 5 years Present with history of fever or reported fever Present with cough or difficult breathing Exclusion Criteria: Age below 6 months and above 5 years Presence of signs and symptoms of severe illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kojo Yeboah-Antwi, MD, MPH
Organizational Affiliation
Center for International Health and Development
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chikankata Health Services
City
Chikankata
State/Province
Southern Province
Country
Zambia

12. IPD Sharing Statement

Citations:
PubMed Identifier
20877714
Citation
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.
Results Reference
derived

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Zambia Integrated Management of Malaria and Pneumonia Study

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