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Trial registered on ANZCTR


Registration number
ACTRN12615000893505
Ethics application status
Approved
Date submitted
31/07/2015
Date registered
26/08/2015
Date last updated
6/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of artesunate+ampdiaquine for the treatment of uncomplicated malaria in district hospital of Massakory, Hadjer Lamis region, Chad
Scientific title
Efficacy and safety of artesunate+ampdiaquine for the treatment of uncomplicated malaria in district hospital of Massakory, Hadjer Lamis region, Chad
Secondary ID [1] 287190 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
NIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 295764 0
Condition category
Condition code
Infection 296046 296046 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To assess the efficacy and safety of artesunate+amodiaquine
(artesunate 4 mg/kg body weight + amodiaquine 10mg/kg body weight once daily for 3 consecutive days) for the treatment of uncomplicated P. falciparum infection. The treatment will be taken orally under direct supervision by the health worker. Eligibile subjects will be treated for three days and followed up for 28 days.
Intervention code [1] 292471 0
Treatment: Drugs
Comparator / control treatment
Not applicable.

This is a surveillance study of one-arm.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295714 0
Percent of treatment failures (early treatment failure + late clinical failure +late parasitological failure). This is composite primary outcome.

Enrolled patients will be assessed for parasitological (using microscopy), clinical responses during the 28 days follow-up and treatment outcomes will be classified according to the latest WHO protocol.
Timepoint [1] 295714 0
At day 28 following initiation of artesunate+amodiaquine
Secondary outcome [1] 316293 0
Percent of adverse event will be documented. The known adverse events of artesunate+amodiaquineare Asthenia, cough, diarrhoea, fever, loss of appetite, nausea, vomiting.

Parents or guardians of all enrolled patients will be asked routinely about previous symptoms and about symptoms that have emerged since the previous follow-up visit. When clinically indicated, patients will be evaluated and treated appropriately. All adverse events will be recorded on the case report form.
Timepoint [1] 316293 0
At day 28 following initiation of treatment.
Secondary outcome [2] 316294 0
Prevalence of artemisinin resistance molecular markers (K13).

Parasite DNA extracted from the dried blood spots will be analyzed by PCR and sequencing for the presence of K13 (molecular marker for artemisinin resistance).
Timepoint [2] 316294 0
At Day 0 (prior initiation of treatment)

Eligibility
Key inclusion criteria
1. age between six months and 5 years;
2. mono-infection with P. falciparum detected by microscopy;
3. parasitaemia of 1000–100,000/microliter asexual forms;
4. presence of axillary temperature greater or equal to 37.5 degrees C or history of fever during the past 24 h
5. ability to swallow oral medication;
6. ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
7.informed consent from the parent or guardian in the case of children
Minimum age
6 Months
Maximum age
5 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO;
2. weight under 5 kg;
3. mixed or mono-infection with another Plasmodium species detected by microscopy;
4. presence of severe malnutrition defined as a child aged 6-60 months has a mid-upper arm circumference belo 115 mm)
5. presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
6. regular medication, which may interfere with antimalarial
pharmacokinetics;
7. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients aged between 6 month and 5 years with uncomplicated malaria who meet the study inclusion criteria will be enrolled, treated on site with artesunate+amodiaquine and monitored for 28 days. The follow-up will consist of a fixed schedule of check-up visits and corresponding clinical and laboratory examinations.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.

This surveillance study is a one-arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated malaria with artesunate+amodiaquine.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Currently the treatment failure rate to
artesunate+amodiaquine in the study area is assumed unknown and assumed to be <50%. At a confidence level of 95% and a precision around the estimate of 10%, a minimum of 96 patients must be included per drug test. With a 20% increase to allow loss to follow-up and withdrawals during the 28-day follow-up period, 103 patients should be included in the study.

Excel WHO tailored database will be used for data management and analysis. Data will be analysed by two methods: the Kaplan-Meier method and per-protocol analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7062 0
Chad
State/province [1] 7062 0
Hadjer-Lamis Region

Funding & Sponsors
Funding source category [1] 291753 0
Government body
Name [1] 291753 0
Ministry of Health of Chad
Address [1] 291753 0
N'djamena
B.P. 440
Country [1] 291753 0
Chad
Primary sponsor type
Government body
Name
Ministry of Health of Chad
Address
N'djamena
B.P. 440
Country
Chad
Secondary sponsor category [1] 290425 0
None
Name [1] 290425 0
Nil
Address [1] 290425 0
Nil
Country [1] 290425 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293274 0
National EThical board
Ethics committee address [1] 293274 0
B.P. 440
N'djamena
Ethics committee country [1] 293274 0
Chad
Date submitted for ethics approval [1] 293274 0
01/06/2015
Approval date [1] 293274 0
14/07/2015
Ethics approval number [1] 293274 0
2192/PR/PM/MSP/SE/SG
Ethics committee name [2] 293275 0
WHO ERC
Ethics committee address [2] 293275 0
20 Av. Appia,
1211 Geneva 27 Switzerland
Ethics committee country [2] 293275 0
Switzerland
Date submitted for ethics approval [2] 293275 0
06/07/2015
Approval date [2] 293275 0
28/07/2015
Ethics approval number [2] 293275 0
ERC.0002631

Summary
Brief summary
Title: Efficacy and safety of artesunate+amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in district hospital of Massakory, Hadier Lamis region of Chad

Purpose: To assess the efficacy and safety of the first-line treatment.

Objective: To assess the efficacy and safety of artesunate+amodiaquine for the treatment of uncomplicated P. falciparum malaria infections.

Study Sites: District hospital of Massakory, Hadier Lamis region of Chad.

Study Period: The study will be conducted from 1 August to 1st October 2015.

Study Design: A one arm prospective study.

Patient population: Febrile patients aged between 6 months and 5 years
with confirmed uncomplicated P. falciparum infection will be enrolled.

Sample Size: A total of 103 patients will be enrolled.

Treatments and follow-up: artesunate+amodiaquine given daily dose for
3 days. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy and safety.

Primary endpoints: The proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy. Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis. Day 3 malaria positivity rate will determined.

Secondary endpoints: The frequency of adverse events and polymorphism of molecular markers for artemisinin resistance.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes
Nil

Contacts
Principal investigator
Name 59222 0
Dr Clement Kerah Hinzoumbe
Address 59222 0
BP 759 Njamena
Country 59222 0
Chad
Phone 59222 0
+23566282431
Fax 59222 0
Email 59222 0
kerah_clement@yahoo.fr
Contact person for public queries
Name 59223 0
Dr Clement Kerah Hinzoumbe
Address 59223 0
BP 759 Njamena
Country 59223 0
Chad
Phone 59223 0
+23566282431
Fax 59223 0
Email 59223 0
kerah_clement@yahoo.fr
Contact person for scientific queries
Name 59224 0
Dr Clement Kerah Hinzoumbe
Address 59224 0
BP 759 Njamena
Country 59224 0
Chad
Phone 59224 0
+23566282431
Fax 59224 0
Email 59224 0
kerah_clement@yahoo.fr

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary