UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003813 |
|---|---|
| Receipt number | R000004601 |
| Scientific Title | Atovaquone-resistant Plasmodium falciparum in Central Africa |
| Date of disclosure of the study information | 2010/07/23 |
| Last modified on | 2014/06/23 17:05:46 |
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Basic information
Public title
Atovaquone-resistant Plasmodium falciparum in Central Africa
Acronym
Atovaquone-resistant malaria
Scientific Title
Atovaquone-resistant Plasmodium falciparum in Central Africa
Scientific Title:Acronym
Atovaquone-resistant malaria
Region
| Africa |
Condition
Condition
target disease - malaria
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To assess the current efficacy and tolerance of atovaquone-proguanil, compared with artesunate-amodiaquine, for the treatment of acute uncomplicated falciparum malaria
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
adequate clinical and parasitological response versus treatment failure on day 28, as defined by the World Health Organization
Key secondary outcomes
parasite and fever clearance times
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
treatment with artesunate-amodiaquine (recommended by the national drug policy)
Interventions/Control_2
treatment with atovaquone-proguanil
Interventions/Control_3
treatment with artesunate-atovaquone-proguanil
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 4 | months-old | <= |
Age-upper limit
| 60 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
fever at the time of consultation, presence of Plasmodium falciparum with a parasite density more than 2,000 asexual parasites per microlitre of blood
Key exclusion criteria
signs and symptoms of severe and complicated malaria (as defined by the World Health Organization), mixed infections with other Plasmodium species, persistent vomiting, hematocrit less than 15%
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Leonardo Basco |
Organization
Institut de Recherche pour le Developpement
Division name
Unite Mixte de Recherche 198
Zip code
Address
Faculte de Medecine La Timone, Universite Aix-Marseille II, 27 boulevard Jean Moulin, 13385 Marseille, France
TEL
330491150149
lkbasco@yahoo.fr
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Herve Tissot-Dupont |
Organization
Institut de Recherche pour le De;veloppement
Division name
Departement Societes et Sante (DSS)
Zip code
Address
Le Sextant, 44 boulevard de Dunkerque, CS90009, 13572 Marseille cedex 02, France
TEL
330491999570
Homepage URL
http://www.ird.fr
dss@ird.fr
Sponsor or person
Institute
Aix-Marseille Universite
Institute
Department
Personal name
Funding Source
Organization
Agence Nationale de la Recherche (ANR)
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
France
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Nlongkak Catholic missionary dispensary, Yaounde, Cameroon
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2007 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 23 | Day |
Last modified on
| 2014 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004601
