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

NCT ID: NCT01002066

Last Updated: 2011-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3890 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-02-28

Brief Summary

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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

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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.

Conditions

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Fever Malaria

Study Design

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Observational Model Type

COHORT

Eligibility Criteria

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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
Minimum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zanzibar Malaria Control Programme

OTHER_GOV

Sponsor Role collaborator

World Health Organization

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anders Björkman

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anders Björkman, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hopsital

Andreas Mårtensson, Ph.D, M.D.

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Kristina Elfving, M.D.

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Mwinyi Msellem, MSc

Role: PRINCIPAL_INVESTIGATOR

Zanzibar Malaria Control Programme

Delér Shakely, M.D.

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hopsital

Locations

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Primary health care centers (PHCC)s and Primary health care units (PHCUs)

Kivunge and Micheweni, Zanzibar, Tanzania

Site Status

Countries

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Tanzania

References

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Shakely D, Elfving K, Aydin-Schmidt B, Msellem MI, Morris U, Omar R, Weiping X, Petzold M, Greenhouse B, Baltzell KA, Ali AS, Bjorkman A, Martensson A. The usefulness of rapid diagnostic tests in the new context of low malaria transmission in Zanzibar. PLoS One. 2013 Sep 4;8(9):e72912. doi: 10.1371/journal.pone.0072912. eCollection 2013.

Reference Type DERIVED
PMID: 24023791 (View on PubMed)

Other Identifiers

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ACT2010

Identifier Type: -

Identifier Source: org_study_id