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Trial of Artesunate Combination Therapy in Pakistan

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00959517
First Posted: August 14, 2009
Last Update Posted: August 14, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
HealthNet TPO
Information provided by:
London School of Hygiene and Tropical Medicine
  Purpose

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 (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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00959517


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Mark Rowland, London School of Hygiene & Tropical Medicine
ClinicalTrials.gov Identifier: NCT00959517     History of Changes
Other Study ID Numbers: T26/181/33 A00017
TDR A00017
First Submitted: August 13, 2009
First Posted: August 14, 2009
Last Update Posted: August 14, 2009
Last Verified: August 2009

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

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artesunate
Chloroquine
Artemisinins
Chloroquine diphosphate
Primaquine
Pyrimethamine
Sulfadoxine
Fanasil, pyrimethamine drug combination
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics
Folic Acid Antagonists
Enzyme Inhibitors