Malaria Clinical Trial
Official title:
Studies on Adding Artesunate to Existing Antimalarial Therapies With Chloroquine, Amodiaquine & Sulphadoxine-pyrimethamine in Pakistan
Chloroquine resistant falciparum malaria in Pakistan is prevalent in every malarious area examined. Resistance to the favoured second-line treatment, sulphadoxine-pyrimethamine S/P is rising fast. To avert a repetition of the resistance catastrophe that occurred in SE Asia it is critical to preserve the effective life of SP by using it in combination with artesunate. Efficacy of ACT with artesunate in combination with chloroquine, SP or amodiaquine for treatment of malaria (falciparum or vivax) will be examined in malaria patients in Pakistan.
Status | Completed |
Enrollment | 650 |
Est. completion date | December 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 70 Years |
Eligibility |
Inclusion Criteria: - adults or children > 5 yrs - weight > 5 kg - monoinfection with P. falciparum or P. vivax - history of recent fever - consent from patient or parent. Exclusion Criteria: - patients with signs of severe malaria. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Pakistan | HealthNet International | Peshawar |
Lead Sponsor | Collaborator |
---|---|
London School of Hygiene and Tropical Medicine | HealthNet TPO, Pakistan Directorate of Malaria Control, United Nations High Commissioner for Refugees, World Health Organization |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Day 7 slide clearance rate (complete clearance of trophozoites) assessed by microscopists who are blind to treatment allocation. | |||
Primary | Day 28 slide clearance rate without subsequent recrudescence. | |||
Primary | Day 7 gametocyte prevalence. | |||
Secondary | Day 14 gametocyte prevalence | |||
Secondary | Fever clearance time | |||
Secondary | cure rate (elimination of parasitaemia without recrudescence). | |||
Secondary | Rate and time of parasite clearance. | |||
Secondary | Rate of resolution of fever. | |||
Secondary | Proportion of gametocyte carriers. | |||
Secondary | Transmissibility of gametocytes through mosquito feeding studies. | |||
Secondary | Tolerability. | |||
Secondary | Molecular characterisation of genetic diversity and resistance before and after treatment. |
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