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

Study Overview
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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.

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

Conditions
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Plasmodium Falciparum Malaria

Intervention / Treatment
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* Device: HRP2 and LDH based rapid diagnostic tests for P.falciparum


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| children with malaria<br>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<br> <br> * Other names: CareStart (pLDH);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance time with five diagnostic tests | 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 | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RDT, malaria, treatment follow up, diagnosis