Last updated: 11/07/2018 17:33:29

An International, Randomized, Open-Label Study to Compare the Safety and Efficacy of MALARONE (Atovaquone and Proguanil Hydrochloride) Versus Chloroquine and Proguanil Hydrochloride for Chemoprophylaxis Against Malaria in Non-Immune Pediatric Travelers

GSK study ID
MAL30012
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An International, Randomized, Open-Label Study to Compare the Safety and Efficacy of MALARONE (Atovaquone and Proguanil Hydrochloride) Versus Chloroquine and Proguanil Hydrochloride for Chemoprophylaxis Against Malaria in Non-Immune Pediatric Travelers
Trial description: An International, Randomized, Open-Label Study to Compare the Safety and Efficacy of MALARONE (Atovaquone and Proguanil Hydrochloride) Versus Chloroquine and Proguanil Hydrochloride for Chemoprophylaxis Against Malaria in Non-Immune Pediatric Travelers
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/proguanil versus chloroquine/proguanil or mefloquine in clinical trials of non-immune paediatric travellers 11-40kg. Camus, D, Malvy, D, Schilthuis, H, Hogh, B, Knobloch, J, Behrens, R H, Kain, K C, Overbosch, D, Hedgley, C A, Roskell, N S, Miller, G B, and Malarone International Study Team 3rd European Conference on Travel Medicine 5/15/2002 Florence; Italy
Abstract: Tolerance, compliance and acceptance of malaroneâ® and savarineâ® for malaria chemoprophylaxis in travellers. Camus, D. 1, Masson, V. 2, Inglebert, P. 2, and Dutoit, E. 1 11th International Congress on Infectious Diseases (ICID) 3/4/2004 Cancun; Mexico
Camus, D., Djossou, F., Schilthuis, H. J., Hogh, B., Dutoit, E., Malvy, D., Roskell, N. S., Hedgley, C., DeBoever, E. H., and Miller, G. B. Atovaquone-proguanil versus chloroquine-proguanil for malaria prophylaxis in nonimmune pediatric travelers: results of an international, randomized, open-label study. Clinical Infectious Diseases. 38(12):1716-1723, 2004
Medical condition
Malaria
Product
atovaquone/proguanil
Collaborators
Not applicable
Study date(s)
May 1999 to December 2000
Type
Not applicable
Phase
3

Participation criteria

Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable

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
2000-29-12

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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