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

May 2, 2013 updated by: Anders Björkman

Efficacy of Plasmodium Falciparum Specific Rapid Diagnostic Tests for Assessment of Initial Clearance and Detection of Recurrent Infections After Antimalarial Treatment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
      • Dar es Salaam, Tanzania, 65001
        • Muhimbili University of Health Allied Science
    • Kibaha and Bagamoyo district
      • Dar es Salaam, Kibaha and Bagamoyo district, Tanzania
        • Mlandizi Health Centre and Fukayosi dispencary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children with fever visiting primary health care units in malaria endemic area

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Device: HRP2 and LDH based rapid diagnostic tests for P.falciparum
Other Names:
  • ParaHit (HRP2)
  • CareStart (pLDH)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clearance time with five diagnostic tests
Time Frame: 2009 June to 2012 May (up to day 42)
Children were followed up on 9 occasions until day 42. Mean and median time until clearance after initiation of arthemeter-lumefantrine treatment was measured for HRP2 based Rapid diagnostic tests, LDH-based Rapid diagnostic tests, Giemsa and Acridine Orange stained microscopy and real-time PCR.
2009 June to 2012 May (up to day 42)
Detection of recurrent infection with HRP2 and LDH-based Rapid diagnostic tests during follow up
Time Frame: 2009 June to 2012 May (up to day 42)
Ability to detect recurrent malaria infection with the HRP2 and LDH-Rapid diagnostic tests during the 42 days of follow up was studied through comparing them with three other diagnostic tests.
2009 June to 2012 May (up to day 42)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficiency of P.falciparum specific rapid diagnostic tests
Time Frame: 2009 June to 2012 May (up to day 42)
Efficiency of two rapid diagnostic tests based on two different antigens for diagnosis and treatment follow up among children <5 years in a moderately high endemic area was determined. Specificity and false positivity rate for HRP2 and LDH based rapid diagnostic tests are calculated against Giemsa stained microscopy and PCR.
2009 June to 2012 May (up to day 42)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anders Björkman

Collaborators

Muhimbili University of Health and Allied Sciences

Investigators

  • Study Director: Anders Björkman, Professor, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

February 15, 2013

First Submitted That Met QC Criteria

April 30, 2013

First Posted (Estimate)

May 1, 2013

Study Record Updates

Last Update Posted (Estimate)

May 3, 2013

Last Update Submitted That Met QC Criteria

May 2, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDT-ClearTZ1
  • KI-MUHAS1 (Registry Identifier: RDT-ClearTZ1)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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