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Trial of Artesunate Combination Therapy in Pakistan

Primary Purpose

Uncomplicated Falciparum Malaria

Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
artesunate (AS)
sulphadoxine-pyrimethamine (SP)
Chloroquine (CQ)
primaquine (PQ)
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uncomplicated Falciparum Malaria focused on measuring Placebo controlled, Efficacy, Artemisinin-based combination therapy, Primaquine, Gametocytes

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • HealthNet International

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

CQ

CQ+PQ

CQ + AS

SP

SP + PQ

SP + AS

Arm Description

Outcomes

Primary Outcome Measures

Parasitological outcome after 28 days follow-up

Secondary Outcome Measures

Asexual parasite clearance by day 7
Gametocyte carriage on or after day 7

Full Information

First Posted
August 13, 2009
Last Updated
August 13, 2009
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
HealthNet TPO
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1. Study Identification

Unique Protocol Identification Number
NCT00959517
Brief Title
Trial of Artesunate Combination Therapy in Pakistan
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
HealthNet TPO

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
A randomised, double-blind placebo controlled study of the efficacy of chloroquine or sulphadoxine-pyrimethamine alone and in combination with primaquine or artesunate for the treatment of uncomplicated falciparum malaria. Arms: CQ CQ+primaquine CQ+ artesunate SP SP+primaquine 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncomplicated Falciparum Malaria
Keywords
Placebo controlled, Efficacy, Artemisinin-based combination therapy, Primaquine, Gametocytes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
588 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CQ
Arm Type
Experimental
Arm Title
CQ+PQ
Arm Type
Experimental
Arm Title
CQ + AS
Arm Type
Experimental
Arm Title
SP
Arm Type
Experimental
Arm Title
SP + PQ
Arm Type
Experimental
Arm Title
SP + AS
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
artesunate (AS)
Intervention Description
Recommended dosage over 3 days (for all interventions)
Intervention Type
Drug
Intervention Name(s)
sulphadoxine-pyrimethamine (SP)
Intervention Type
Drug
Intervention Name(s)
Chloroquine (CQ)
Intervention Type
Drug
Intervention Name(s)
primaquine (PQ)
Primary Outcome Measure Information:
Title
Parasitological outcome after 28 days follow-up
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Asexual parasite clearance by day 7
Time Frame
7 days
Title
Gametocyte carriage on or after day 7
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark W Rowland, PhD
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
HealthNet International
City
Peshawar
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
22303437
Citation
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.
Results Reference
derived

Learn more about this trial

Trial of Artesunate Combination Therapy in Pakistan

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