Trial of Artesunate Combination Therapy in Pakistan

This study has been completed.
Sponsor:
Collaborator:
HealthNet TPO
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00959517
First received: August 13, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Asexual parasite clearance by day 7 [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Gametocyte carriage on or after day 7 [ Time Frame: 7 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by London School of Hygiene and Tropical Medicine

Additional 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
Study First Received: August 13, 2009
Last Updated: August 13, 2009
Health Authority: Pakistan: Research Ethics Committee

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
Parasitic Diseases
Protozoan Infections
Artesunate
Chloroquine
Chloroquine diphosphate
Fanasil, pyrimethamine drug combination
Primaquine
Pyrimethamine
Sulfadoxine
Amebicides
Analgesics
Analgesics, Non-Narcotic
Anthelmintics
Anti-Infective Agents
Anti-Infective Agents, Urinary
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antimalarials
Antinematodal Agents
Antiparasitic Agents
Antiprotozoal Agents
Antirheumatic Agents
Central Nervous System Agents
Enzyme Inhibitors
Filaricides
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 23, 2014