CTRI/2017/09/009594
Recruiting
未知
A multi-centre, open-label randomised trial to assess the effi-cacy, safety and tolerability of Triple Artemisinin-based Combination Therapies (TACTs) compared to Artemisinin-based Combination Therapies (ACTs) in uncomplicated fal-ciparum malaria and to map the geographical spread of artemisinin and partner drug resistance.
K Department for International Development DFID0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Male or female aged 6 months to 65 years old with Acute uncomplicated P falciparum malaria
- Sponsor
- K Department for International Development DFID
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Acute uncomplicated P. falciparum malaria confirmed by positive blood smear with asexual forms of P. falciparum
- •Asexual P. falciparum parasitaemia: 5,000 to 200,000/uL, determined on a thin or thick blood film
- •Fever defined as \> 37\.5°C tympanic temperature or a history of fever within the last 24 hours
- •Written informed consent (by parent/guardian in case of chil\-dren)
- •Willingness and ability of the patients or parents/guardians to comply with the study protocol for the duration of the study
Exclusion Criteria
- •Signs of severe/complicated malaria
- •Haematocrit \< 25% or Hb \< 8 g/dL at enrollment
- •Acute illness other than malaria requiring treatment
- •For females: pregnancy, breast feeding
- •Patients who have received artemisinin or a derivative or an artemisinin\-containing combination therapy (ACT) within the previous 7 days
- •Antimalarial therapy in past Two months
- •Previous splenectomy
- •Documented or claimed history of cardiac conduction prob\-lems
- •Earlier participation within the TRACII trial or another trial in the previous 3 months.
Outcomes
Primary Outcomes
Not specified
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