Improved Clinical and Microscopy Diagnosis at Primary Health Care in Tanzania

Malaria Clinical Trial

Official title:

Quality Malaria Case Management In Under- Fives In Primary Health Care (Phc) Institutions In Bagamoyo And Kibaha Districts Of Coastal Tanzania:a Multicomponent Controlled Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00687895
• Other study ID #: HF2003
• Status: Completed
• Phase: Phase 4
• First received: May 28, 2008
• Last updated: May 28, 2008
• Start date: July 2003
• Est. completion date: March 2004

Study information

• Verified date: May 2008
• Source: Muhimbili University of Health and Allied Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tanzania: National Institute for Medical Research
• Study type: Interventional

Clinical Trial Summary

General objective: To improve the quality of fever case management in children in government health facilities in Tanzania Hypothesis:The training of health workers, as well as provision, training and use of microscopes for malaria diagnosis will improve the treatment of clinical episodes of fever in children while reducing the amount and costs of drugs

Description:

PHC facilities were eligible for the study if they were rural government owned; accessible by road during rainy season; and within 3 hours by car from Muhimbili University College of Health Sciences (MUCHS), Dar es Salaam

All children attending the 16 PHC facilities under the study during daytime were enrolled if they fulfilled the following criteria:

1. below five years of age

2. fever (temperature≥37.5◦C) and/or reported history of fever in last 2 days

3. able to return to the facility on day 7 after treatment or any other day if symptoms were to worsen or recur

4. the mother/guardian or caretaker consented to participate.

Patients with severe disease and/or general danger signs requiring inpatient care according to the IMCI guidelines were admitted or referred to the health centers or the district hospitals

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3131
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

Inclusion Criteria:

1. below five years of age

2. fever (temperature=37.5?C) and/or reported history of fever in last 2 days

3. able to return to the facility on day 7 after treatment or any other day if symptoms were to worsen or recur

4. the mother/guardian or caretaker consented to participate

Exclusion Criteria:

a) N/A

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Malaria

Intervention

Procedure:
• Clinical algorithm and microscopy diagnosis of malaria
Clinical alogarithm The content of the package included description of signs and symptoms of malaria disease history taking relevant to malaria and physical examination identification of danger signs and severe illness for referral appropriate treatment counseling patients on the use of drugs. Malaria microscopy. contents make thick blood smears from patients with fever and stain with Giemsa identify and count malaria parasites maintain the microscope and store blood slides.

Locations

Country	Name	City	State
Tanzania	dispensaries/health centers in Kibaha and Bagamoyo	Coast

Sponsors (2)

Lead Sponsor	Collaborator
Muhimbili University of Health and Allied Sciences	Karolinska Institutet

Country where clinical trial is conducted

Tanzania, 

References & Publications (1)

Bates I, Bekoe V, Asamoa-Adu A. Improving the accuracy of malaria-related laboratory tests in Ghana. Malar J. 2004 Nov 1;3:38. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the proportion of study children receiving prescriptions of antimalarial drugs in the respective arms		Day 0	No
Secondary	prescriptions of antibiotics, cost of drugs		Day 0	No
Secondary	health outcome of the patients		Day 1-6, day 7	No