MalariaPhase 4NCT00935688
Examination of ACT Implementation in a Vivax / Falciparum Co-endemic Area
A Phase 4 study testing Rapid diagnostic test in people with Malaria and Fever, run by London School of Hygiene and Tropical Medicine at 2 sites in Afghanistan.
Trial summary
In areas of which are co-endemic for vivax and falciparum malaria, treatments for the two diseases often differ and this may lead to mistreatment. This places an emphasis on diagnosis at the health service provision level. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Rapid diagnostic test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,200 participants
- Where
- 2 sitesAfghanistan
- Study dates
- May 2009to Oct 2010
- 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
- Any patient where the clinician* considers malaria in the diagnosis - either prescribing an antimalarial or would request a malaria test if available or referring for diagnosis of malaria elsewhere.
- Patient, or parent/guardian, gives informed consent to the study.
Who cannot join
- Patients with a result from another facility
- Patients referred on for diagnosis in the private sector
- Patients the clinician decides to treat presumptively without requesting a test (defined as treating prior to randomisation)
- Where the clinician requests microscopy specifically due to clinical need prior to randomisation will not be randomised in the trial, but will be noted as part of the study and a reference slide and clinical information will be taken following consent.
Trial locations and contacts
2 sites in 1 country.
Afghanistan2 sites
HealthNet TPO
Jalalabad, Nangarhar
Merlin
Kunduz, Kunduz
About this study
Official title: An Examination of ACT Strategy in South-central Asia on Falciparum Malaria in a Context Where Vivax is the Major Species
In areas of which are co-endemic for vivax and falciparum malaria, treatments for the two diseases often differ and this may lead to mistreatment. This places an emphasis on diagnosis at the health service provision level. Diagnosis is also important when malaris endemicity is low - most fevers are not caused by disease. These two issues mean that most malaria and fevers are not adequately treated, even though the drugs may be effective; many patients who do not have malaria are treated for the disease, and patients with malaria may get the wrong treatment for their species. The study aims to test the effectiveness of employing rapid diagnostic tests and will study the effect on correct treatment.
Read the detailed description
The study will randomly assign diagnostic methods, either with clinical diagnosis, field microscopy or rapid diagnostic tests. The study will take place in 22 clinics in Eastern and Northern Afghanistan, both areas with low transmission of predominantly vivax malaria. They differ in their locations and their current standard diagnostic methods.
The study will examine the result of the diagnostic test in the clinic against the result of reference slides and PCR to estimate the number of cases correctly treated in each arm. This will be a measure of the effectiveness of diagnosis (and the physicians response to the diagnosis) and be influential in considering modalities for diagnostic delivery
- Being tested
- Rapid diagnostic test
- Keywords
- malaria, rapid diagnostic tests, afghanistan, Non-specific fever
- Medical subject headings
- Malaria, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid diagnostic testOther
Dual species test for P. vivax and P. falciparum malaria
| Study group | Role | What they receive |
|---|---|---|
| Rapid diagnostic tests | Experimental | malaria diagnosis by rapid diagnostic test Receives: Other: Rapid diagnostic test |
| Clinic Microscopy | No intervention | malaria diagnosed with field light-microscopy |
| Clinical Diagnosis | No intervention | Malaria diagnosed on the basis of clinical symptoms alone (i.e. not laboratory diagnosis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients correctly treated
Composite measure defined as patients with Pf malaria receiving ACT Drugs; Pv malaria receiving CQ; patients with no malaria receiving no antimalarial drugs.
NOTE: Previously reported here as "Proportion of patients incorrectly treated" being 1 minus the Proportion correctly treated. No change in how the outcome was measured.
Measured: 2009-2010
Secondary outcomes (2)
% of PV patients not receiving CQ % of PF patients not receiving SP/AS
Measured: 2009-2010
Diagnostic Accuracy of the different malaria tests
Sensitivity and specificity of mRDTs, Microscopy and clinical diagnosis.
Measured: 2009-2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Health Protection and Research Organisation, HealthNet TPO, Medical Emergency Relief International (Merlin)
- Responsible party
- Principal investigator, Mark Rowland, London School of Hygiene and Tropical Medicine
- Investigators
- Toby Leslie, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935688
- Sponsor's protocol ID
- ACT Consortium
- Status last verified
- Feb 2014
- First submitted
- 8 Jul 2009
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hansen KS, Grieve E, Mikhail A, Mayan I, Mohammed N, Anwar M, Baktash SH, Drake TL, Whitty CJ, Rowland MW, Leslie TJ. Cost-effectiveness of malaria diagnosis using rapid diagnostic tests compared to microscopy or clinical symptoms alone in Afghanistan. Malar J. 2015 May 28;14:217. doi: 10.1186/s12936-015-0696-1.
PubMed 26016871Leslie T, Mikhail A, Mayan I, Cundill B, Anwar M, Bakhtash SH, Mohammed N, Rahman H, Zekria R, Whitty CJ, Rowland M. Rapid diagnostic tests to improve treatment of malaria and other febrile illnesses: patient randomised effectiveness trial in primary care clinics in Afghanistan. BMJ. 2014 Jun 19;348:g3730. doi: 10.1136/bmj.g3730.
PubMed 24948695
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Examination of ACT Strategy in South-central Asia on Falciparum Malaria in a Context Where Vivax is the Major Species
- ClinicalTrials.gov ID
- NCT00935688
- Acronym / sponsor ID
- ACT Consortium
- Keywords
- malaria, rapid diagnostic tests, afghanistan, Non-specific fever
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,200 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Health Protection and Research Organisation, HealthNet TPO, Medical Emergency Relief International (Merlin)
- Study start
- May 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 9 Jul 2009 (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.
In areas of which are co-endemic for vivax and falciparum malaria, treatments for the two diseases often differ and this may lead to mistreatment. This places an emphasis on diagnosis at the health service provision level. Diagnosis is also important when malaris endemicity is low - most fevers are not caused by disease. These two issues mean that most malaria and fevers are not adequately treated, even though the drugs may be effective; many patients who do not have malaria are treated for the disease, and patients with malaria may get the wrong treatment for their species. The study aims to test the effectiveness of employing rapid diagnostic tests and will study the effect on correct treatment.
Detailed description
The study will randomly assign diagnostic methods, either with clinical diagnosis, field microscopy or rapid diagnostic tests. The study will take place in 22 clinics in Eastern and Northern Afghanistan, both areas with low transmission of predominantly vivax malaria. They differ in their locations and their current standard diagnostic methods.
The study will examine the result of the diagnostic test in the clinic against the result of reference slides and PCR to estimate the number of cases correctly treated in each arm. This will be a measure of the effectiveness of diagnosis (and the physicians response to the diagnosis) and be influential in considering modalities for diagnostic delivery
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rapid diagnostic tests | Experimental | Other: Rapid diagnostic testmalaria diagnosis by rapid diagnostic test |
| Clinic Microscopy | No intervention | –malaria diagnosed with field light-microscopy |
| Clinical Diagnosis | No intervention | –Malaria diagnosed on the basis of clinical symptoms alone (i.e. not laboratory diagnosis) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Any patient where the clinician* considers malaria in the diagnosis - either prescribing an antimalarial or would request a malaria test if available or referring for diagnosis of malaria elsewhere.
- Patient, or parent/guardian, gives informed consent to the study.
Key exclusion criteria (4 listed)
- Patients with a result from another facility
- Patients referred on for diagnosis in the private sector
- Patients the clinician decides to treat presumptively without requesting a test (defined as treating prior to randomisation)
- Where the clinician requests microscopy specifically due to clinical need prior to randomisation will not be randomised in the trial, but will be noted as part of the study and a reference slide and clinical information will be taken following consent.
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 testDual species test for P. vivax and P. falciparum malaria | Other | Rapid diagnostic tests |
Primary outcome
Proportion of patients correctly treated
Time frame: 2009-2010
Composite measure defined as patients with Pf malaria receiving ACT Drugs; Pv malaria receiving CQ; patients with no malaria receiving no antimalarial drugs. NOTE: Previously reported here as "Proportion of patients incorrectly treated" being 1 minus the Proportion correctly treated. No change in how the outcome was measured.
2 secondary outcomes
% of PV patients not receiving CQ % of PF patients not receiving SP/AS
Time frame: 2009-2010
Diagnostic Accuracy of the different malaria tests
Time frame: 2009-2010
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 7 Feb 2014.
- Derived from this study: PubMed 26016871Hansen KS, Grieve E, Mikhail A, Mayan I, Mohammed N, Anwar M, Baktash SH, Drake TL, Whitty CJ, Rowland MW, Leslie TJ. Cost-effectiveness of malaria diagnosis using rapid diagnostic tests compared to microscopy or clinical symptoms alone in Afghanistan. Malar J. 2015 May 28;14:217. doi: 10.1186/s12936-015-0696-1.
- Derived from this study: PubMed 24948695Leslie T, Mikhail A, Mayan I, Cundill B, Anwar M, Bakhtash SH, Mohammed N, Rahman H, Zekria R, Whitty CJ, Rowland M. Rapid diagnostic tests to improve treatment of malaria and other febrile illnesses: patient randomised effectiveness trial in primary care clinics in Afghanistan. BMJ. 2014 Jun 19;348:g3730. doi: 10.1136/bmj.g3730.
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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.
Toby Leslie, PhD principal investigator
London School of Hygiene and Tropical Medicine
2 sites 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 in people with Malaria and Fever, run by London School of Hygiene and Tropical Medicine at 2 sites in Afghanistan.
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 4 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 7 Feb 2014. 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 Afghanistan. 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?
Proportion of patients correctly treated (time frame: 2009-2010). 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 NCT00935688, which also lists 2 linked publications.
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 7 Feb 2014.