Uncomplicated Plasmodium Falciparum MalariaPhase 4NCT00301015
Rapid Diagnostic Testing and Artemisinin-Based Combination Therapy for Uncomplicated Malaria by Community Health Workers
A Phase 4 study testing Rapid diagnostic test for malaria in people with Uncomplicated Plasmodium Falciparum Malaria, run by Karolinska University Hospital at 1 site in Tanzania.
Trial summary
The purpose of this study is to evaluate the efficiency of a rapid diagnostic test (Paracheck Pf) for the diagnosis of uncomplicated Plasmodium falciparum malaria by community health workers at village level in Tanzania and how the use of rapid diagnostic test may influence prescription of antimalarial drugs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Uncomplicated Plasmodium Falciparum Malaria
- What is being tested?
- Rapid diagnostic test for malaria
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,005 participants
- Where
- 1 siteTanzania
- Study dates
- Mar 2006to Aug 2006
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Fever
- Informed consent
Who cannot join
- Severe clinical manifestations, which require immediate referral
- Pregnancy
- Previous enrollment in the study within the last 28 days
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the efficiency of a rapid diagnostic test (Paracheck Pf) for the diagnosis of uncomplicated Plasmodium falciparum malaria by community health workers at village level in Tanzania and how the use of rapid diagnostic test may influence prescription of antimalarial drugs.
The hypothesis is that rapid diagnostic tests used by community health workers will reduce the use of antimalarial drugs (Coartem; Novartis) by 30% without affecting the health outcome.
- Being tested
- Rapid diagnostic test for malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid diagnostic test for malariaDevice
We used Paracheck Pf® (Orchid Biomedical Systems, India) as rapid diagnostic test in this trial
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Malaria diagnosis aided with rapid diagnostic test Receives: Device: Rapid diagnostic test for malaria |
| 2 | Active comparator | Malaria diagnosis based on clinical judgement only Receives: Device: Rapid diagnostic test for malaria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with fever prescribed artemether-lumefantrine for the treatment of malaria in respective study groups
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2006 (estimated)
- Study startMar 2006
- Study completionAug 2006
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 Uncomplicated 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 3,005 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Investigators
- Anders Björkman, MD, PhD, Study director, Dept of Medicine, Karolinska University Hospital, 171 76 Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301015
- Sponsor's protocol ID
- RapAct 28-02-2006
- Status last verified
- Oct 2007
- First submitted
- 8 Mar 2006
- Last updated
- 1 Nov 2007
- Results posted
- No
Publications
Mubi M, Janson A, Warsame M, Martensson A, Kallander K, Petzold MG, Ngasala B, Maganga G, Gustafsson LL, Massele A, Tomson G, Premji Z, Bjorkman A. Malaria rapid testing by community health workers is effective and safe for targeting malaria treatment: randomised cross-over trial in Tanzania. PLoS One. 2011;6(7):e19753. doi: 10.1371/journal.pone.0019753. Epub 2011 Jul 5.
PubMed 21750697
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Diagnostic Testing and Artemisinin-Based Combination Therapy for Uncomplicated Malaria by Community Health Workers
- ClinicalTrials.gov ID
- NCT00301015
- Acronym / sponsor ID
- RapAct 28-02-2006
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,005 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Study start
- Mar 2006
- Study completion
- Aug 2006 (actual)
- First posted
- 10 Mar 2006 (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 purpose of this study is to evaluate the efficiency of a rapid diagnostic test (Paracheck Pf) for the diagnosis of uncomplicated Plasmodium falciparum malaria by community health workers at village level in Tanzania and how the use of rapid diagnostic test may influence prescription of antimalarial drugs.
The hypothesis is that rapid diagnostic tests used by community health workers will reduce the use of antimalarial drugs (Coartem; Novartis) by 30% without affecting the health outcome.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Rapid diagnostic test for malariaMalaria diagnosis aided with rapid diagnostic test |
| 2 | Active comparator | Device: Rapid diagnostic test for malariaMalaria diagnosis based on clinical judgement only |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Fever
- Informed consent
Key exclusion criteria (3 listed)
- Severe clinical manifestations, which require immediate referral
- Pregnancy
- Previous enrollment in the study within the last 28 days
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 |
|---|---|---|
| Rapid diagnostic test for malariaWe used Paracheck Pf® (Orchid Biomedical Systems, India) as rapid diagnostic test in this trial | Device | 1, 2 |
Primary outcome
Number of patients with fever prescribed artemether-lumefantrine for the treatment of malaria in respective study groups
Time frame: 28 days
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 1 Nov 2007.
- Derived from this study: PubMed 21750697Mubi M, Janson A, Warsame M, Martensson A, Kallander K, Petzold MG, Ngasala B, Maganga G, Gustafsson LL, Massele A, Tomson G, Premji Z, Bjorkman A. Malaria rapid testing by community health workers is effective and safe for targeting malaria treatment: randomised cross-over trial in Tanzania. PLoS One. 2011;6(7):e19753. doi: 10.1371/journal.pone.0019753. Epub 2011 Jul 5.
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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, MD, PhD study director
Dept of Medicine, Karolinska University Hospital, 171 76 Stockholm, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rapid diagnostic test for malaria in people with Uncomplicated Plasmodium Falciparum Malaria, run by Karolinska University Hospital at 1 site 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 2 inclusion and 3 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 1 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of patients with fever prescribed artemether-lumefantrine for the treatment of malaria in respective study groups (time frame: 28 days). 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 NCT00301015, 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 1 Nov 2007.