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Trial of Artesunate Combination Therapy in Pakistan

This study has been completed.
HealthNet TPO
Information provided by:
London School of Hygiene and Tropical Medicine Identifier:
First received: August 13, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted

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.

Condition Intervention Phase
Uncomplicated Falciparum Malaria
Drug: artesunate (AS)
Drug: sulphadoxine-pyrimethamine (SP)
Drug: Chloroquine (CQ)
Drug: primaquine (PQ)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Parasitological outcome after 28 days follow-up [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • Asexual parasite clearance by day 7 [ Time Frame: 7 days ]
  • Gametocyte carriage on or after day 7 [ Time Frame: 7 days ]

Enrollment: 588
Study Start Date: July 2001
Study Completion Date: August 2006
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CQ Drug: Chloroquine (CQ)
Experimental: CQ+PQ Drug: Chloroquine (CQ) Drug: primaquine (PQ)
Experimental: CQ + AS Drug: artesunate (AS)
Recommended dosage over 3 days (for all interventions)
Drug: Chloroquine (CQ)
Experimental: SP Drug: sulphadoxine-pyrimethamine (SP)
Experimental: SP + PQ Drug: sulphadoxine-pyrimethamine (SP) Drug: primaquine (PQ)
Experimental: SP + AS Drug: artesunate (AS)
Recommended dosage over 3 days (for all interventions)
Drug: sulphadoxine-pyrimethamine (SP)

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.


  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.


Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00959517

HealthNet International
Peshawar, Pakistan
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
HealthNet TPO
Principal Investigator: Mark W Rowland, PhD London School of Hygiene and Tropical Medicine
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Mark Rowland, London School of Hygiene & Tropical Medicine Identifier: NCT00959517     History of Changes
Other Study ID Numbers: T26/181/33 A00017
TDR A00017
Study First Received: August 13, 2009
Last Updated: August 13, 2009

Keywords provided by London School of Hygiene and Tropical Medicine:
Placebo controlled
Artemisinin-based combination therapy

Additional relevant MeSH terms:
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Fanasil, pyrimethamine drug combination
Chloroquine diphosphate
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents processed this record on April 25, 2017