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Zambia Integrated Management of Malaria and Pneumonia Study (ZIMMAPS)
This study is not yet open for participant recruitment.
Verified by Boston University, August 2007
Sponsors and Collaborators: Boston University
Center for International Health and Development
United States Agency for International Development (USAID)
Information provided by: Boston University
ClinicalTrials.gov Identifier: NCT00513500
  Purpose

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.


Condition Intervention
Community Health Care
Drug: Coartem and amoxicillin
Drug: Coartem

MedlinePlus related topics: Malaria Pneumonia
Drug Information available for: Amoxicillin Amoxicillin sodium Amoxicillin trihydrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Zambia Integrated Management of Malaria and Pneumonia Study

Further study details as provided by Boston University:

Primary Outcome Measures:
  • Measure proportion of children who receive early and appropriate treatment for pneumonia [ Time Frame: one year ]
  • Determine the extent to which the use of RDTs by CHWs reduces the use of Coartem in managing children with acute fever [ Time Frame: one year ]

Secondary Outcome Measures:
  • Measure proportion of children who do not respond to treatment [ Time Frame: one year ]
  • Measure the cost-effectiveness of CHWs managing malaria using Coartem with RDTs [ Time Frame: one year ]

Estimated Enrollment: 2931
Study Start Date: September 2007
Estimated Study Completion Date: November 2009
Arms Assigned Interventions
1: Experimental
Give treatment normally given at rural health center
Drug: Coartem and amoxicillin
Perform RDT and give Coartem for malaria and give amoxicillin for fast breathing
2: Active Comparator
Give community health post treatment
Drug: Coartem
Give Coartem without RDT and refer fast breathing

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..

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513500

Contacts
Contact: Kojo Yeboah-Antwi, MD, MPH 617-414-1275 kyantwi@bu.edu
Contact: Davidson Hamer, MD 617-414-1267 dhamer@bu.edu

Locations
Zambia, Southern Province
Chikankata Health Services
Chikankata, Southern Province, Zambia
Sponsors and Collaborators
Boston University
Center for International Health and Development
United States Agency for International Development (USAID)
Investigators
Principal Investigator: Kojo Yeboah-Antwi, MD, MPH Center for International Health and Development
  More Information

Study ID Numbers: GHS-A-00-00020-00-5
Study First Received: August 7, 2007
Last Updated: August 8, 2007
ClinicalTrials.gov Identifier: NCT00513500  
Health Authority: United States: Institutional Review Board;   Zambia: Research Ethics Committee

Keywords provided by Boston University:
community health worker
malaria
pneumonia
rapid diagnostic test

Study placed in the following topic categories:
Benflumetol
Artemether-lumefantrine combination
Protozoan Infections
Amoxicillin
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Parasitic Diseases
Malaria
Pneumonia
Artemether

Additional relevant MeSH terms:
Antimalarials
Anti-Infective Agents
Anti-Bacterial Agents
Antiparasitic Agents
Antiprotozoal Agents
Coccidiosis
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009