Trial of Artesunate Combination Therapy in Pakistan

Uncomplicated Falciparum Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959517
• Other study ID #: T26/181/33 A00017
• Secondary ID: TDR A00017
• Status: Completed
• Phase: Phase 2
• First received: August 13, 2009
• Last updated: August 13, 2009
• Start date: July 2001
• Est. completion date: August 2006

Study information

• Verified date: August 2009
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 588
• Est. completion date: August 2006
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• Uncomplicated Falciparum Malaria

Intervention

Drug:
• artesunate (AS)
Recommended dosage over 3 days (for all interventions)
• sulphadoxine-pyrimethamine (SP)

• Chloroquine (CQ)

• primaquine (PQ)

Locations

Country	Name	City	State
Pakistan	HealthNet International	Peshawar

Sponsors (2)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	HealthNet TPO

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parasitological outcome after 28 days follow-up		28 days	No
Secondary	Asexual parasite clearance by day 7		7 days	No
Secondary	Gametocyte carriage on or after day 7		7 days	No