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
2 other identifiers
observational
53
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2009
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 15, 2013
CompletedFirst Posted
Study publicly available on registry
May 1, 2013
CompletedMay 3, 2013
May 1, 2013
1.8 years
February 15, 2013
May 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Efficiency of P.falciparum specific rapid diagnostic tests
2009 June to 2012 May (up to day 42)
Study Arms (1)
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
Interventions
Eligibility Criteria
Children with fever visiting primary health care units in malaria endemic area
You may qualify if:
- 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
You may not qualify if:
- children with history of antimalaria drug intake within the last two weeks
- symptoms / signs of severe disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Mlandizi Health Centre and Fukayosi dispencary
Dar es Salaam, Kibaha and Bagamoyo District, Tanzania
Muhimbili University of Health Allied Science
Dar es Salaam, 65001, Tanzania
Related Publications (1)
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.
PMID: 24079306DERIVED
Biospecimen
Whole capillary blood collected for Rapid Diagnostic tests, microscopy and PCR
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anders Björkman, Professor
Karolinska Institutet
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 15, 2013
First Posted
May 1, 2013
Study Start
June 1, 2009
Primary Completion
April 1, 2011
Study Completion
June 1, 2012
Last Updated
May 3, 2013
Record last verified: 2013-05