Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000627752
Ethics application status
Approved
Date submitted
29/05/2013
Date registered
31/05/2013
Date last updated
31/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of the fixed combinations of artemether-lumefantrine and artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in sentinel sites of Melen (Estuary) and of Franceville (Haut Ogooue) in Gabon
Scientific title
Efficacy and safety of the fixed combinations of artemether-lumefantrine and artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in sentinel sites of Melen (Estuary) and of Franceville (Haut Ogooue) in Gabon
Secondary ID [1] 282575 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uncomplicated Plasmodium falciparum malaria 289255 0
Condition category
Condition code
Infection 289577 289577 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a surveillance study to monitor the efficacy and safety of the first-line (Arsucam) and second-line (Coartem) antimalarial treatments for uncomplicated falciparum malaria in children Gabon. Eligible patients will be treated with either Arsucam or Coartem (adult tablet or pediatric dispersible tablet). Both drugs will be tested in each of the two sentinel sites; allocation to treatment will be by randomization to avoid the risk of having insufficient patients in one of the two groups at the end of the study period. Patients assigned to Arsucam will be treated with one of the three tablets strengths formulation conatining 25 mg artesunate/67.5 mg amodiaquine; 50 mg artesunate/135 amodiaquine; 100 mg artesunate/270 mg amodiaquine. Coartem tablet containing 20 mg artemether and 120 mg lumefantrine will be used in children over 15 kg, and Coartem dispersible tablets containing 10 mg artemether and 60 mg lumefantrine will be used for children from 5 to 15 kg body weight. The tablets strength and number of tablets to be administered daily will be based on body weight according to standard of care. Coartem daily dose will be administered twice a day and Coarsucam daily dose will be administered once a day. Both treaments will be administered for three consecutive days by study staff. Patients will be seen for clinical and parasitological evaluation, daily for the first 3 days, and then weekly until day 28 or at any time if symptoms re-occurred.
Intervention code [1] 287237 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289704 0
Proportion of patients with adequate clinical and parasitological response adjusted by PCR (polymerase chain reaction)
Timepoint [1] 289704 0
Day 28
Secondary outcome [1] 303054 0
Nature and incidence of adverse events. Possible adverse events are those known to occur with antimalarials and include, headache, body ache nausea, vomiting, abdominal discomfort, liver enzyme elevation and dizziness. Clinical laboratory tests may be performed to confirm a diagnosis.
Timepoint [1] 303054 0
Day 28

Eligibility
Key inclusion criteria
Axillary temperature equal or greater than 37.5 degrees Celsius or history of fever in the past 24 hours.
Parasitemia, asexual forms between 2000 and 200 000 per microliter of blood.
Mono-infection with plasmodium falciparum confirmed by microscopy.
Age between 12 months and 12 years.
Body weight greater than 5 kg.
Absence of clinical signs of severe malaria
Absence of known serious chronic disease.
Absence of severe malnutrition.
Capacity to swallow oral medication.
Capable and willing to follow protocol requirement including schedule of assessments
Consent from parent or guardian.
Assent from children aged 11 and 12 years.
Minimum age
1 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of general danger signs in children aged under 5 years, or signs of severe falciparum malaria according to WHO definition.
Mixed or mono-infection with another Plasmodium species detected by microscopy.
Presence of severe malnutrition (defined as a child whose growth standard is below minus 3z-score, has symmetrical oedema involving at least the feet, or has mid-upper arm circumference less than 110 mm.
Presence of febrile conditions due to diseases other than malaria (measles, acute lowest respiratory tract infection, severe dirrhoea with dehydration) or other known underlyning chronic diseases (cardiac, renal and hepatic diseases, HIV/AIDS).
Regular medication, which may interfere with animalarial pharmacokinetics;
History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatments
Likehood of pre-pubescence or pubescence in female.
Refusal to consent.
Not capable to comply with visit schedule.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/06/2013
Actual
Date of last participant enrolment
Anticipated
31/05/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
288
Accrual to date
Final
Recruitment outside Australia
Country [1] 5122 0
Gabon
State/province [1] 5122 0
Melen (Estuaire)
Country [2] 5123 0
Gabon
State/province [2] 5123 0
Franceville (Haut Ogooue)

Funding & Sponsors
Funding source category [1] 287377 0
Government body
Name [1] 287377 0
PNLP Ministere de la Sante GABON
Country [1] 287377 0
Gabon
Primary sponsor type
Government body
Name
PNLP Ministere de la Sante GABON
Address
c/o Dr Etienne NZENGUE
B.P. 50 Libreville
Country
Gabon
Secondary sponsor category [1] 286123 0
None
Name [1] 286123 0
Address [1] 286123 0
Country [1] 286123 0
Other collaborator category [1] 277440 0
University
Name [1] 277440 0
Dr Thierry Fandeur
Centre International de Recherches Medicales de Franceville
Address [1] 277440 0
B.P. 769
Franceville
Country [1] 277440 0
Gabon
Other collaborator category [2] 277441 0
University
Name [2] 277441 0
Dr Marielle Bouyou-Akotet
Universite des Sciences de la Sante-GABON
Departement de Parasitologie et de Mycologie
Address [2] 277441 0
B.P. 4009
Libreville
Country [2] 277441 0
Gabon

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289352 0
Ethics Research Committee, World Health Organisation
Ethics committee address [1] 289352 0
20 Ave Appia
1211 Gneva 27
Ethics committee country [1] 289352 0
Switzerland
Date submitted for ethics approval [1] 289352 0
18/03/2013
Approval date [1] 289352 0
21/05/2013
Ethics approval number [1] 289352 0
RPC 567

Summary
Brief summary
An open-label study to monitor the efficacy and safety of the first and second line antimalarials, artesuante-amodiaquine (Arsucam) and artemether-lumefantrine (Coartem) for the treatment of uncomplicated falciparum malaria in children in Melen (Estuaire) and in Franceville (Haut-Ogooue) in Gabon. The primary outcome is the proportion of patients with adequate clinical and parasitological response PCR-adjusted at day 28.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40334 0
Dr Thierry Fandeur
Address 40334 0
Centre International de Recherches Medicales de Franceville
B.P. 769
Franceville
Country 40334 0
Gabon
Phone 40334 0
+241 07 61 57 70
Fax 40334 0
Email 40334 0
thierryfandeur@yahoo.fr
Contact person for public queries
Name 40335 0
Dr Dr Etienne NZENGUE
Address 40335 0
PNLP Ministere de la Sante GABON
B.P. 50 Libreville
Country 40335 0
Gabon
Phone 40335 0
+241 77 56 43
Fax 40335 0
Email 40335 0
nzenguetienne@yahoo.fr
Contact person for scientific queries
Name 40336 0
Dr Thierry Fandeur
Address 40336 0
Centre International de Recherches Medicales de Franceville
B.P. 769
Franceville
Country 40336 0
Gabon
Phone 40336 0
+241 07 61 57 70
Fax 40336 0
Email 40336 0
thierryfandeur@yahoo.fr

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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