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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01843764
Enrollment
53
Registered
2013-05-01
Start date
2009-06-30
Completion date
2012-06-30
Last updated
2013-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plasmodium Falciparum Malaria

Keywords

RDT, malaria, treatment follow up, diagnosis

Brief summary

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.

Interventions

DEVICEHRP2 and LDH based rapid diagnostic tests for P.falciparum

Sponsors

Muhimbili University of Health and Allied Sciences
CollaboratorOTHER
Anders Björkman
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clearance time with five diagnostic tests2009 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.
Detection of recurrent infection with HRP2 and LDH-based Rapid diagnostic tests during follow up2009 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

MeasureTime frameDescription
Efficiency of P.falciparum specific rapid diagnostic tests2009 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.

Countries

Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026