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Effectiveness Of Rapid Diagnostic Tests in the New Context of Low Malaria Endemicity in Zanzibar

Rapid Malaria Diagnostic Tests in Fever Patients Attending Primary Health Care Facilities in Zanzibar - Effectiveness as Diagnostic and Surveillance Tool in the New Context of Low Malaria Endemicity

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01002066
Acronym
RDTACT
Enrollment
3890
Registered
2009-10-27
Start date
2010-05-31
Completion date
2011-02-28
Last updated
2011-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever, Malaria

Keywords

Fever, Malaria, RDT, IMCI, Children<5 years of age, ACT

Brief summary

The purpose of this study is to study the effectiveness of wide scale RDT use at the primary health care level in previously high malaria endemic area during malaria pre-elimination phase for improved targeting of anti-malarial drugs, malaria surveillance and epidemic alertness.

Detailed description

During the last 6 years Zanzibar has undergone a dramatic change in malaria epidemiology and burden of disease, with a marked decline of Plasmodium falciparum malaria among febrile children from approximately 30% to 1% or below and a reduction of crude child mortality of 50% Overuse of the expensive ACTs will not only be a substantial financial burden on the health care system in Zanzibar, but will also spur anti-malarial drug resistance with devastating effect on global malaria control efforts and prevent other causes of fever from being appropriately treated, e.g. pneumonias which require antibiotics. Rapid Diagnostic Tests (RDTs), based on antigen detection of P. falciparum, are proposed as a future cornerstone to improve diagnostic efficiency also at the peripheral health care level beyond the reach of microscopy services IMCI algorithms based on clinical symptoms could potentially be made more efficient and cost effective if simple parasitological diagnostic methodologies were incorporated. Zanzibar is among the first regions to incorporate RDT in the IMCI guidelines in Africa, which provides a unique research opportunity to scientifically evaluate the effectiveness of incorporating RDT in the existing IMCI algorithm. Another key challenge for Zanzibar is to monitor potential development of parasite resistance to ACT when the number of malaria positive patients is insufficient to conduct standard in vivo efficacy trials. We propose that RDT could play a critical new role also in this regard.

Interventions

None listed

Sponsors

Zanzibar Malaria Control Programme
CollaboratorOTHER_GOV
World Health Organization
CollaboratorOTHER
Karolinska University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT

Eligibility

Sex/Gender
ALL
Age
2 Months to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients \>2 months of age with confirmed fever, with a measured axillary temperature of ≥37.5˚C, or history of fever within the preceding 24 hours * Presenting to the health facility from 8.00 to 16.00 Monday to Friday. * Informed consent

Exclusion criteria

* Previous enrolment in the study within the last 28 days. * Severe disease that requires immediate referral as defined by the clinician

Design outcomes

Primary

MeasureTime frame
Adherence to Rapid diagnostic tests (RDT) resultFive months

Countries

Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026