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

August 13, 2009
August 13, 2009
July 2001
June 2005   (final data collection date for primary outcome measure)
Parasitological outcome after 28 days follow-up [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Uncomplicated Falciparum Malaria
  • Drug: artesunate (AS)
    Recommended dosage over 3 days (for all interventions)
  • Drug: sulphadoxine-pyrimethamine (SP)
  • Drug: Chloroquine (CQ)
  • Drug: primaquine (PQ)
  • Experimental: CQ
    Intervention: Drug: Chloroquine (CQ)
  • Experimental: CQ+PQ
    Interventions:
    • Drug: Chloroquine (CQ)
    • Drug: primaquine (PQ)
  • Experimental: CQ + AS
    Interventions:
    • Drug: artesunate (AS)
    • Drug: Chloroquine (CQ)
  • Experimental: SP
    Intervention: Drug: sulphadoxine-pyrimethamine (SP)
  • Experimental: SP + PQ
    Interventions:
    • Drug: sulphadoxine-pyrimethamine (SP)
    • Drug: primaquine (PQ)
  • Experimental: SP + AS
    Interventions:
    • Drug: artesunate (AS)
    • Drug: sulphadoxine-pyrimethamine (SP)
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. Epub 2012 Jan 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
588
August 2006
June 2005   (final data collection date for primary outcome measure)

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
Both
2 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Pakistan
 
NCT00959517
T26/181/33 A00017, TDR A00017
Yes
Dr Mark Rowland, London School of Hygiene & Tropical Medicine
London School of Hygiene and Tropical Medicine
HealthNet TPO
Principal Investigator: Mark W Rowland, PhD London School of Hygiene and Tropical Medicine
London School of Hygiene and Tropical Medicine
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP