Zambia Integrated Management of Malaria and Pneumonia Study

Malaria Clinical Trial

— ZIMMAPS  

Official title:

Zambia Integrated Management of Malaria and Pneumonia Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00513500
• Other study ID #: GHS-A-00-00020-00-5
• Status: Completed
• Phase: N/A
• First received: August 7, 2007
• Last updated: July 13, 2010
• Start date: June 2007
• Est. completion date: September 2009

Study information

• Verified date: July 2010
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardZambia: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3125
• Est. completion date: September 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 5 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Malaria
• Pneumonia

Intervention

Drug:
• Coartem and amoxicillin
Perform RDT and give Coartem for malaria and give amoxicillin for fast breathing
• Coartem
Give Coartem without RDT and refer fast breathing

Locations

Country	Name	City	State
Zambia	Chikankata Health Services	Chikankata	Southern Province

Sponsors (3)

Lead Sponsor	Collaborator
Boston University	Center for International Health and Development, United States Agency for International Development (USAID)

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Number of Children With Fever Who Received Coartem (Artemether-lumefantrine)		one year	No
Secondary	Number of Children Who do Not Respond to Treatment for Pneumonia		one year	Yes