Last updated: 11/07/2018 17:33:39
An Open-Label Comparative Study to Determine the Safety and Efficacy of MALARONE (Atovaquone and Proguanil Hydrochloride) Versus Amodiaquine in the Treatment of Acute Plasmodium falciparum Malaria in Children Weighing 5 and <11kg in Gabon
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An Open-Label Comparative Study to Determine the Safety and Efficacy of MALARONE (Atovaquone and Proguanil Hydrochloride) Versus Amodiaquine in the Treatment of Acute Plasmodium falciparum Malaria in Children Weighing 5 and <11kg in Gabon
Trial description: An Open-Label Comparative Study to Determine the Safety and Efficacy of MALARONE (Atovaquone and Proguanil Hydrochloride) Versus Amodiaquine in the Treatment of Acute Plasmodium falciparum Malaria in Children Weighing 5 and <11kg in Gabon
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Abstract: Atovaquone and proguanil versus amodiaquine in the treatment of uncomplicated plasmodium falciparum malaria in children weighing >+5 and <11 kg in gabon. Borrmann, S, Faucher, J F, Binder, R K, Miller, G B, Lell, B, and Kremsner, P G American Society of Tropical Medicine and Hygiene 50th Annual Meeting 11/11/2001 Atlanta, GA; USA
Abstract: Atovaquone and proguanil versus amodiaquine in the treatment of uncomplicated plasmodium falciparum malaria in children weighing 5 and < 11kg in gabon. Faucher, J F, Binder, R K, Lell, B, Kremsner, P G, Borrmann, S, and Miller, G B 3rd European Congress on Tropical Medicine and International Health 9/8/2002 Lisbon; Portugal
Borrmann S. Faucher JF. Bagaphou T. Missinou MA. Binder RK. Pabisch S. Rezbach P. Matsiegui PB. Lell B. Miller G. Kremsner PG. Atovaquone and proguanil versus amodiaquine for the treatment of Plasmodium falciparum malaria in African infants and young children. Clinical Infectious Diseases. 37(11):1441-7, 2003
Medical condition
Malaria, Falciparum
Product
atovaquone/proguanil
Collaborators
Not applicable
Study date(s)
January 1999 to December 2000
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2000-06-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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