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CompletedNCT00549003ZRDTUpdated Oct 25, 2007

Efficacy and Cost Effectiveness of Malaria Diagnosis Procedures and the Rational Use of ACT in Zanzibar

A Phase 4 interventional study of Rapid Diagnostic Test for P. falciparum malaria in Malaria, sponsored by Karolinska University Hospital. Completed at 1 site in Tanzania. Per ClinicalTrials.gov, last updated 2007-10-25.

Sponsored by Karolinska University Hospital · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
9,346
Allocation
Randomized
Sex
All
01

Study summary

The purpose of this study is to assess performance and cost-effectiveness of rapid diagnostic test(RDT) aided malaria diagnosis versus symptom-based/clinical diagnosis in patients of all ages with reported fever last 48 hours alone in primary health care settings in Zanzibar.

02

Conditions studied

  • Malaria

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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 9,346 is above the median of 220 across 1,027 interventional studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

Karolinska University Hospital is the lead sponsor of 275 studies on the registry; 54 are open to participants now.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Any patient attending the study sites and reporting history of fever within past 48 hours or other symptoms compatible with malaria and giving their informed consent, will be eligible for the study.

Exclusion criteria

Exclusion Criteria:

  • Patient's refusal to consent will disqualify participation in the study.
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Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
9,346 participants (actual)

Interventions

  • DeviceRapid Diagnostic Test for P. falciparum malaria

    Also known as: Paracheck Pf, Manufactured by Orchid Biomedical Systems, Goa, INDIA.

06

Study locations

1 site
  • Muyuni, Uzini, Kinyasini and Mzambarauni Primary Health Care Units
    Zanzibar, Tanzania
07

References and documents

Publications

  • Msellem MI, Martensson A, Rotllant G, Bhattarai A, Stromberg J, Kahigwa E, Garcia M, Petzold M, Olumese P, Ali A, Bjorkman A. Influence of rapid malaria diagnostic tests on treatment and health outcome in fever patients, Zanzibar: a crossover validation study. PLoS Med. 2009 Apr 28;6(4):e1000070. doi: 10.1371/journal.pmed.1000070. Epub 2009 Apr 28. PubMed 19399156 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00549003
Lead sponsor
Karolinska University Hospital
First posted
Oct 25, 2007
Start date
Feb 2005
Completion
Aug 2005
Last update
Oct 25, 2007

Study contacts

Anders Björkman, MD,PhD
study director · Karolinska UH
Mwinyi I Msellem, HLSO
principal investigator · Karolinska UH

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

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