Trial of Artesunate Combination Therapy in Pakistan
Pseudo-randomised, Double-blinded Placebo-controlled Trial of Chloroquine or Sulphadoxine-pyrimethamine Alone or in Combination With Primaquine or Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Pakistan
2 other identifiers
interventional
588
1 country
1
Brief Summary
This study is an evaluation of the benefit of adding artesunate to existing first and second line antimalarial therapies in Pakistan. A placebo controlled trial was carried out to assess two potential benefits of Artesunate Combination Therapy (ACT): efficacy and potential for transmission reduction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2001
Longer than P75 for phase_2
1 active site
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
July 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 13, 2009
CompletedFirst Posted
Study publicly available on registry
August 14, 2009
CompletedAugust 14, 2009
August 1, 2009
3.9 years
August 13, 2009
August 13, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Parasitological outcome after 28 days follow-up
28 days
Secondary Outcomes (2)
Asexual parasite clearance by day 7
7 days
Gametocyte carriage on or after day 7
7 days
Study Arms (6)
CQ
EXPERIMENTALCQ+PQ
EXPERIMENTALCQ + AS
EXPERIMENTALSP
EXPERIMENTALSP + PQ
EXPERIMENTALSP + AS
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- presentation at basic health unit with suspected clinical malaria
- 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
You may not qualify if:
- other serious disease (e.g., cardiac, renal or hepatic)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- London School of Hygiene and Tropical Medicinelead
- HealthNet TPOcollaborator
Study Sites (1)
HealthNet International
Peshawar, Pakistan
Related Publications (1)
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.
PMID: 22303437DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark W Rowland, PhD
London School of Hygiene and Tropical Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 13, 2009
First Posted
August 14, 2009
Study Start
July 1, 2001
Primary Completion
June 1, 2005
Study Completion
August 1, 2006
Last Updated
August 14, 2009
Record last verified: 2009-08