Rapid Diagnostic Tests for Assessment of Initial Clearance and Detection of Recurrent Malaria Infections

NCT ID: NCT01843764

Last Updated: 2013-05-03

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

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-06-30

Brief Summary

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The aim of the study was to follow clearance of malaria infections and detection of new malaria episodes after initiation of antimalarial treatment in Tanzanian children. For this purpose the investigators used five diagnostic tools, 2 Rapid Diagnostic tests based on Histidine Rich Protein 2(HRP2) and Lactate dehydrogenase(LDH), 2 microscopical methods and one polymerase chain reaction (PCR). The investigators followed the 53 enrolled children during 42 days.

Detailed Description

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Conditions

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Plasmodium Falciparum Malaria

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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children with malaria

Tanzanian children between 6-59 months with an uncomplicated P.falciparum monoinfection, followed after arthemeter-lumefantrine treatment according to national treatment guidelines

HRP2 and LDH based rapid diagnostic tests for P.falciparum

Intervention Type DEVICE

Interventions

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HRP2 and LDH based rapid diagnostic tests for P.falciparum

Intervention Type DEVICE

Other Intervention Names

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ParaHit (HRP2) CareStart (pLDH)

Eligibility Criteria

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Inclusion Criteria

* children between 6-59 months
* fever (≤37.5 C) or history of fever during the preceding 24 hours
* confirmed P.falciparum monoinfection
* uncomplicated malaria
* parasite density between 2000-250.000/µL
* willing/able to comply with the 42 day follow up
* informed concent from patient/guardian

Exclusion Criteria

* children with history of antimalaria drug intake within the last two weeks
* symptoms / signs of severe disease
Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Muhimbili University of Health and Allied Sciences

OTHER

Sponsor Role collaborator

Anders Björkman

OTHER

Sponsor Role lead

Responsible Party

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Anders Björkman

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Anders Björkman, Professor

Role: STUDY_DIRECTOR

Karolinska Institutet

Locations

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Mlandizi Health Centre and Fukayosi dispencary

Dar es Salaam, Kibaha and Bagamoyo District, Tanzania

Site Status

Muhimbili University of Health Allied Science

Dar es Salaam, , Tanzania

Site Status

Countries

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Tanzania

References

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Aydin-Schmidt B, Mubi M, Morris U, Petzold M, Ngasala BE, Premji Z, Bjorkman A, Martensson A. Usefulness of Plasmodium falciparum-specific rapid diagnostic tests for assessment of parasite clearance and detection of recurrent infections after artemisinin-based combination therapy. Malar J. 2013 Oct 1;12:349. doi: 10.1186/1475-2875-12-349.

Reference Type DERIVED
PMID: 24079306 (View on PubMed)

Other Identifiers

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KI-MUHAS1

Identifier Type: REGISTRY

Identifier Source: secondary_id

RDT-ClearTZ1

Identifier Type: -

Identifier Source: org_study_id

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