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Completed

NCT Number: NCT01843764

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

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.

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Key information

Conditions

Plasmodium Falciparum Malaria Disease Infections Malaria Malaria, Falciparum Mosquito-Borne Diseases Parasitic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Protozoan Infections Vector Borne Diseases

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Mlandizi Health Centre and Fukayosi dispencary, Dar es Salaam, Kibaha and Bagamoyo District, Tanzania

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HRP2 and LDH based rapid diagnostic tests for P.falciparum

Device

Other names: ParaHit (HRP2), CareStart (pLDH)

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Anders Björkman

Other

Collaborators

  • Muhimbili University of Health and Allied Sciences

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
May 1, 2013
Registry last updated
May 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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