Plasmodium Falciparum MalariaNCT01843764
Rapid Diagnostic Tests for Assessment of Initial Clearance and Detection of Recurrent Malaria Infections
An observational study of Plasmodium Falciparum Malaria, run by Anders Björkman at 2 sites in Tanzania.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Plasmodium Falciparum Malaria
- What is being tested?
- HRP2 and LDH based rapid diagnostic tests for P.falciparum
- Type of treatment
- Medical device
- How many people
- 53 participants
- Where
- 2 sitesTanzania
- Study dates
- Jun 2009to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Study population: Children with fever visiting primary health care units in malaria endemic area
Who may be able to join
- 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
Who cannot join
- children with history of antimalaria drug intake within the last two weeks
- symptoms / signs of severe disease
Trial locations and contacts
2 sites in 1 country.
Tanzania2 sites
Mlandizi Health Centre and Fukayosi dispencary
Dar es Salaam, Kibaha and Bagamoyo District
Muhimbili University of Health Allied Science
Dar es Salaam, 65001
About this study
Official title: 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.
- Conditions
- Plasmodium Falciparum Malaria
- Being tested
- HRP2 and LDH based rapid diagnostic tests for P.falciparum
- Keywords
- RDT, malaria, treatment follow up, diagnosis
- Medical subject headings
- Malaria, Falciparum, Malaria, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRP2 and LDH based rapid diagnostic tests for P.falciparumDevice
Also called ParaHit (HRP2), CareStart (pLDH)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: HRP2 and LDH based rapid diagnostic tests for P.falciparum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2009 June to 2012 May (up to day 42)
Secondary outcomes (1)
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.
Measured: 2009 June to 2012 May (up to day 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startJun 2009
- Primary completionApr 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plasmodium Falciparum MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anders Björkman
- Sponsor type
- University, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Responsible party
- Sponsor-investigator, Anders Björkman, Karolinska University Hospital
- Investigators
- Anders Björkman, Professor, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843764
- Sponsor's protocol ID
- RDT-ClearTZ1
- Other IDs
- KI-MUHAS1
- Status last verified
- May 2013
- First submitted
- 15 Feb 2013
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24079306
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Plasmodium Falciparum Specific Rapid Diagnostic Tests for Assessment of Initial Clearance and Detection of Recurrent Infections After Antimalarial Treatment
- ClinicalTrials.gov ID
- NCT01843764
- Acronym / sponsor ID
- RDT-ClearTZ1
- Conditions
- Plasmodium Falciparum Malaria
- Keywords
- RDT, malaria, treatment follow up, diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Anders BjörkmanUniversity, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Study start
- Jun 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 1 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children with malaria | – | Device: HRP2 and LDH based rapid diagnostic tests for P.falciparumTanzanian children between 6-59 months with an uncomplicated P.falciparum monoinfection, followed after arthemeter-lumefantrine treatment according to national treatment guidelines |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with fever visiting primary health care units in malaria endemic area
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- children with history of antimalaria drug intake within the last two weeks
- symptoms / signs of severe disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRP2 and LDH based rapid diagnostic tests for P.falciparumAlso: ParaHit (HRP2), CareStart (pLDH) | Device | children with malaria |
Primary outcome
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.
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.
1 secondary outcome
Efficiency of P.falciparum specific rapid diagnostic tests
Time frame: 2009 June to 2012 May (up to day 42)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
- Derived from this study: PubMed 24079306Aydin-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Björkman, Professor study director
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plasmodium Falciparum Malaria, run by Anders Björkman at 2 sites in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance time with five diagnostic tests (time frame: 2009 June to 2012 May (up to day 42)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01843764, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2013.