Clinical trial NCT00959517: Trial of Artesunate Combination Therapy in Pakistan
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uncomplicated Falciparum Malaria
Keywords: Placebo controlled
Efficacy
Artemisinin-based combination therapy
Primaquine
Gametocytes
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: HealthNet TPO
First posted: 2009-08-14
Enrollment: 588
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Parasitological outcome after 28 days follow-up
timeFrame: 28 days
Secondary outcomes:
measure: Asexual parasite clearance by day 7
timeFrame: 7 days
measure: Gametocyte carriage on or after day 7
timeFrame: 7 days
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: HealthNet International
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Mark W Rowland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1371/journal.pone.0028957. Epub 2012 Jan 31.