Clinical TrialID 6134
Superiority of ArTiMist Versus Quinine in Children With Severe Malaria
NCT01258049
Plasmodium Falciparum Malaria
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 6134
- Evidence Id
- 6134
- Core Evidence Id
- 6134
- Source Clinical Trial Id
- 6120
- Herb2 Clinical Trial Id
- HBCT006120
- Nct Id
- NCT01258049
- Title
- Superiority of ArTiMist Versus Quinine in Children With Severe Malaria
- Status
- Completed
- Phase
- Phase 3
- Study Result
- Yes
- Study Condition
- Plasmodium Falciparum Malaria
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: Artemether Sublingual Spray|DRUG: Quinine
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Child, Adult, Older_Adult
- Enrollment
- 151
- Outcome Measure
- Parasitological Success (MITT), Parasitological success defined as a reduction in parasite count of ≥ 90% of baseline at 24 hours after the first dose, 24 hours after start of treatment|Parasitological Success (PP), Parasitological success defined as a reduction in parasite count of ≥ 90% of baseline at 24 hours after the first dose, 24 hours after start of treatment
- Sponsor Collaborator
- Proto Pharma Ltd
- Funded By
- INDUSTRY
- Location
- Centre National de Recherche et de Formation sur le Paludisme (CNRFP), Ouagadougou, 01 BP 2208, Burkina Faso|Navrongo Health Research Centre, Navrongo, P.O. Box 114, Ghana|Rwinkwavu District Hospital, Rwinkwavu, Eastern Province, Rwanda
- Other Id
- ART004
- Start Date
- 2010-12
- Primary Completion Date
- 2012-08
- Completion Date
- 2012-09
- First Posted
- 2010-12-10
- Results First Posted
- 2014-02-28
- Last Update Posted
- 2014-02-28
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT01258049
- Title Cn
- Title En
- Superiority of ArTiMist Versus Quinine in Children With Severe Malaria
- Bilingual Status
- semi_complete