Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
588 participants
INTERVENTIONAL
2001-07-31
2006-08-31
Brief Summary
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A placebo controlled trial was carried out to assess two potential benefits of Artesunate Combination Therapy (ACT): efficacy and potential for transmission reduction.
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Detailed Description
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Arms:
1. CQ
2. CQ+primaquine
3. CQ+ artesunate
4. SP
5. SP+primaquine
6. SP+artesunate
Patients were allocated to treatment groups using a pseudo-randomised table split by age and sex.
Primary outcomes:
* Clinical and parasitological cure/treatment failure by day 28.
Secondary outcomes:
* time to resolution of fever
* time to clearance of trophozoites
* time to clearance of gametocytes
* gametocyte carriage on or after day 7 after treatment
All clinical assessments and slide readings were carried out by staff blind to treatment arm. Slides were double read.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CQ
Chloroquine (CQ)
CQ+PQ
Chloroquine (CQ)
primaquine (PQ)
CQ + AS
artesunate (AS)
Recommended dosage over 3 days (for all interventions)
Chloroquine (CQ)
SP
sulphadoxine-pyrimethamine (SP)
SP + PQ
sulphadoxine-pyrimethamine (SP)
primaquine (PQ)
SP + AS
artesunate (AS)
Recommended dosage over 3 days (for all interventions)
sulphadoxine-pyrimethamine (SP)
Interventions
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artesunate (AS)
Recommended dosage over 3 days (for all interventions)
sulphadoxine-pyrimethamine (SP)
Chloroquine (CQ)
primaquine (PQ)
Eligibility Criteria
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Inclusion Criteria
* mono-infection infection with P. falciparum confirmed by microscopy
* over 2 years of age (no upper age restriction)
* weight over 5 kg (no upper weight restriction)
* if of child bearing age then non-pregnant and willing to remain so for the duration of the study
* greater than 1 asexual parasite per 10 fields
* understands and is willing to sign the consent form
* a resident in the study site willing to collaborate for a full period of follow-up
* no signs of severe malaria
Exclusion Criteria
* in women of child bearing age, pregnancy
* allergy to any of the study drugs or related compounds
* reports to have used any malaria drugs in the last 21 days
* other species of malaria seen
* signs of severe malaria
2 Years
ALL
No
Sponsors
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HealthNet TPO
OTHER
London School of Hygiene and Tropical Medicine
OTHER
Responsible Party
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London School of Hygiene & Tropical Medicine
Principal Investigators
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Mark W Rowland, PhD
Role: PRINCIPAL_INVESTIGATOR
London School of Hygiene and Tropical Medicine
Locations
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HealthNet International
Peshawar, , Pakistan
Countries
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References
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Kolaczinski K, Leslie T, Ali I, Durrani N, Lee S, Barends M, Beshir K, Ord R, Hallett R, Rowland M. Defining Plasmodium falciparum treatment in South West Asia: a randomized trial comparing artesunate or primaquine combined with chloroquine or SP. PLoS One. 2012;7(1):e28957. doi: 10.1371/journal.pone.0028957. Epub 2012 Jan 31.
Other Identifiers
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TDR A00017
Identifier Type: -
Identifier Source: secondary_id
T26/181/33 A00017
Identifier Type: -
Identifier Source: org_study_id
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