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

Malaria Clinical Trial

— RDTACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01002066
• Other study ID #: ACT2010
• Status: Completed
• Phase: N/A
• First received: October 26, 2009
• Last updated: November 14, 2011
• Start date: May 2010
• Est. completion date: February 2011

Study information

• Verified date: November 2011
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Regional Ethical Committee, Stockholm, Sweden:Ministry of Health (MoH) reaserch Council, Zanzibar, Tanzania:
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3890
• Est. completion date: February 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months and older

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Fever
• Malaria

Locations

Country	Name	City	State
Tanzania	Primary health care centers (PHCC)s and Primary health care units (PHCUs)	Kivunge and Micheweni	Zanzibar

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska University Hospital	World Health Organization, Zanzibar Malaria Control Programme

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to Rapid diagnostic tests (RDT) result		Five months	No

External Links

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