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CompletedNCT00687895Updated Jun 2, 2008

Improved Clinical and Microscopy Diagnosis at Primary Health Care in Tanzania

A Phase 4 interventional study of Clinical algorithm and microscopy diagnosis of malaria in Malaria, sponsored by Muhimbili University of Health and Allied Sciences. Completed at 1 site in Tanzania. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2008-06-02.

Sponsored by Muhimbili University of Health and Allied Sciences · Phase 4, Interventional, and Health services research

Phase
Phase 4
Study type
Interventional
Enrollment
3,131
Allocation
Randomized
Ages
6 Months to 59 Months
Sex
All
01

Study 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

Read the detailed 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

02

Conditions studied

  • Malaria

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Keywords

  • malaria microscopy primary health care children
03

In context

Malaria

1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's enrollment of 3,131 is above the median of 220 across 1,027 interventional studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

Muhimbili University of Health and Allied Sciences is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 59 Months
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

a) N/A

05

Study design

Phase
Phase 4
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3,131 participants (actual)

Study arms

  • Experimental
    1

    training in clinical algorithm plus microscopy

    Procedure: Clinical algorithm and microscopy diagnosis of malaria

  • Experimental
    2

    clinical algorithm

    Procedure: Clinical algorithm and microscopy diagnosis of malaria

  • No intervention
    3

    Control

Interventions

  • ProcedureClinical algorithm and microscopy diagnosis of malaria

    Clinical alogarithm The content of the package included 1. description of signs and symptoms of malaria disease 2. history taking relevant to malaria and physical examination 3. identification of danger signs and severe illness for referral 4. appropriate treatment 5. counseling patients on the use of drugs. Malaria microscopy. contents 1. make thick blood smears from patients with fever and stain with Giemsa 2. identify and count malaria parasites 3. maintain the microscope and store blood slides.

06

What researchers measure

Primary outcomes

  1. the proportion of study children receiving prescriptions of antimalarial drugs in the respective arms

    Time frame: Day 0

Secondary outcomes

  1. prescriptions of antibiotics, cost of drugs

    Time frame: Day 0

  2. health outcome of the patients

    Time frame: Day 1-6, day 7

07

Study locations

1 site
  • dispensaries/health centers in Kibaha and Bagamoyo
    Coast, Tanzania
08

References and documents

Publications

  • Bates I, Bekoe V, Asamoa-Adu A. Improving the accuracy of malaria-related laboratory tests in Ghana. Malar J. 2004 Nov 1;3:38. doi: 10.1186/1475-2875-3-38. PubMed 15516269 ↗
  • Ngasala B, Mubi M, Warsame M, Petzold MG, Massele AY, Gustafsson LL, Tomson G, Premji Z, Bjorkman A. Impact of training in clinical and microscopy diagnosis of childhood malaria on antimalarial drug prescription and health outcome at primary health care level in Tanzania: a randomized controlled trial. Malar J. 2008 Oct 2;7:199. doi: 10.1186/1475-2875-7-199. PubMed 18831737 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00687895
Lead sponsor
Muhimbili University of Health and Allied Sciences
Collaborators
Karolinska Institutet
First posted
Jun 2, 2008
Start date
Jul 2003
Primary completion
Mar 2004
Completion
Mar 2004
Last update
Jun 2, 2008

Study contacts

Anders Bjorkman, MD
study director · Karolinska Institutet

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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