Zambia Integrated Management of Malaria and Pneumonia Study (ZIMMAPS)

This study has been completed.
Sponsor:
Collaborators:
Center for International Health and Development
United States Agency for International Development (USAID)
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT00513500
First received: August 7, 2007
Last updated: July 13, 2010
Last verified: July 2010
  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
Pneumonia
Malaria
Drug: Coartem and amoxicillin
Drug: Coartem

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Zambia Integrated Management of Malaria and Pneumonia Study

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Number of Children Who Received Early and Appropriate Treatment for Pneumonia. [ Time Frame: one year ] [ Designated as safety issue: No ]
    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) [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Children Who do Not Respond to Treatment for Pneumonia [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 3125
Study Start Date: June 2007
Study Completion Date: September 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Perform RDT and give Coartem for malaria and give amoxicillin for fast breathing
Active Comparator: 2
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513500

Locations
Zambia
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

No publications provided by Boston University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kojo Yeboah-Antwi, Center for International Health and Development
ClinicalTrials.gov Identifier: NCT00513500     History of Changes
Other Study ID Numbers: GHS-A-00-00020-00-5
Study First Received: August 7, 2007
Results First Received: April 27, 2010
Last Updated: July 13, 2010
Health Authority: United States: Institutional Review Board
Zambia: Research Ethics Committee

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

Additional relevant MeSH terms:
Malaria
Pneumonia
Protozoan Infections
Parasitic Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Artemether-lumefantrine combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on September 22, 2014