Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000182897
Ethics application status
Approved
Date submitted
6/02/2012
Date registered
10/02/2012
Date last updated
10/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Routine monitoring and evaluation of efficacy and safety of artesunate-mefloquine (ASMQ) in Pailin, and dihydroartemisinin-piperaquine (DP) in Pursat, Kratie, and Preah Vihear for the treatment of uncomplicated Plasmodium falciparum malaria, Cambodia 2011
Scientific title
Routine monitoring and evaluation of efficacy and safety of artesunate-mefloquine (ASMQ) in Pailin, and dihydroartemisinin-piperaquine (DP) in Pursat, Kratie, and Preah Vihear for the treatment of uncomplicated Plasmodium falciparum malaria, Cambodia 2011
Secondary ID [1] 279893 0
Nil
Universal Trial Number (UTN)
U1111-1128-0202
Trial acronym
TESCAM2011
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 285794 0
Condition category
Condition code
Infection 285972 285972 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Drugs are dihydroartemisinin-piperaquine (DP) and artesunate-mefloquine (ASMQ). One group was treatedwith DP daily over 3 days, and another group was treated with ASMQ daily over 3 days for uncomplicated Plasmodium falciparum malaria.

DP (oral tablet) with a dose of 4mg/kg for D and 20mg/kg for P daily for 3 days based on the weight group

ASMQ (oral tablet) with AS at a dose of 11-14 mg/kg and with MQ at a dose of 22-28 mg/kg daily based on the weight group
Intervention code [1] 284216 0
Treatment: Drugs
Comparator / control treatment
No control and comparator group. This is a single group trial. In falciparum infected patients, only ASMQ was tested in Pailin and DP was tested in Veal Veng, Preah Vihear and Kratie sites.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286470 0
42-day cure rate or ACPR (adequate clinical and parasitological response for falciparum cases
42-day PCR-corrected ACPR (PCR: polymerase chain reaction, a molecular tool/test to differentiate if the failure is a true resistance or reinfection) for falciparum cases only
Timepoint [1] 286470 0
at the end of 42-day follow up for falciparum cases
Secondary outcome [1] 295944 0
Reported signs and symptoms of adverse effects during the time of drug administration were collected in the case record form. The patients may experience the following adverse effect.

1 Dizziness
2 Headache
3 Vestige
4 Nausea
5 Vomiting
6 Diarrhea
7 Abdomen pain
8 Dark Urine
Timepoint [1] 295944 0
first 3 days after drug administration

Eligibility
Key inclusion criteria
- Equal to or greater than 2 years old;
-Mono Infection with P. falciparum;
-Parasitaemia, 500–200 000 asexual forms per microlitre for P.f;
-Axillary temperature greater than 37.5 degree C
-Ability to swallow oral medication;
-Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
-Informed consent from the patient or from a parent or guardian in case of children.
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Unmarried females aged 12-18 years old
-Presence of general danger signs among children <5 years old or other signs of severe and complicated falciparum malaria according to current WHO definitions;
-Mixed species;
-Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhea with dehydration, etc.),
-Known hypersensitivity or allergy to artesunate or mefloquine
-Known psychiatric disorders, e.g. depression or epilepsy
-Anti arrhythmic or others drugs which are known to influence cardiac function

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)
This is a modified single group study where participants received the same drug per site per specie infection. Patients were enrolled in a sequential manner as they come for consultation at the study site and satisfy the inclusion criteria.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
16/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment outside Australia
Country [1] 4114 0
Cambodia
State/province [1] 4114 0
Pailin
Country [2] 4115 0
Cambodia
State/province [2] 4115 0
Pursat
Country [3] 4116 0
Cambodia
State/province [3] 4116 0
Preah Vihear

Funding & Sponsors
Funding source category [1] 284663 0
Other
Name [1] 284663 0
WHO
Country [1] 284663 0
Philippines
Primary sponsor type
Other
Name
Global Fund For Malaria
Address
# 372 Monivong Blvd, Phnom Penh, Cambodia
Country
Cambodia
Secondary sponsor category [1] 283568 0
Government body
Name [1] 283568 0
National Centre for Parasitology, Entomology and Malaria Control
Address [1] 283568 0
#372 Monivong Blvd, Phnom Penh Cambodia
Country [1] 283568 0
Cambodia
Other collaborator category [1] 260522 0
Other
Name [1] 260522 0
Institude Paster du Cambodge
Address [1] 260522 0
Monivong Blvd, Phnom Penh Cambodia
Country [1] 260522 0
Cambodia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286666 0
National Ethics Comittee for Health Research
Ethics committee address [1] 286666 0
#2 Kim YL Sung Blvd, Khan Tuol Kok, Phnom Penh, Cambodia
Ethics committee country [1] 286666 0
Cambodia
Date submitted for ethics approval [1] 286666 0
17/06/2011
Approval date [1] 286666 0
21/06/2011
Ethics approval number [1] 286666 0
073NECHR
Ethics committee name [2] 286693 0
World Health Organization Western Pacific Regional Office Ethics Review Committee (WHO-WPRO ERC)
Ethics committee address [2] 286693 0
World Health Organization Western Pacific Regional Office
United Nations Avenue, 1000 Manila
Ethics committee country [2] 286693 0
Philippines
Date submitted for ethics approval [2] 286693 0
04/08/2011
Approval date [2] 286693 0
24/08/2011
Ethics approval number [2] 286693 0
2011.11.CAM.02.MVP

Summary
Brief summary
This study was a one-arm prospective evaluation of the clinical and parasitological responses to directly observed treatment for uncomplicated falciparum. The objective is to assess the efficacy and safety of dihydroartemisinin-piperaquine (DP) in Pursat, Kratie and Preah Vihear, and artesunate-mefloquine (ASMQ) in Pailin for the treatment of uncomplicated Plasmodium falciparum malaria. The WHO 42-day in vivo protocol was used. Patients with uncomplicated P.f malaria who met the study inclusion criteria were enrolled and treated on site with DP or ASMQ and monitored weekly for 42 days for P.f cases. The follow-up consists of a fixed schedule of check-up visits and corresponding clinical and laboratory examinations. On the basis of the results of these assessments, the patients were classified as having therapeutic failure (early or late) or an adequate response. The proportion of patients experiencing therapeutic failure during the follow-up period were used to estimate the efficacy of the study drug. PCR analysis were used to distinguish between a true recrudescence or reinfection. The results of this study are being used to assist the Ministry of Health of Cambodia in assessing the current national treatment guidelines for uncomplicated Plasmodium falciparum malaria.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 33745 0
Address 33745 0
Country 33745 0
Phone 33745 0
Fax 33745 0
Email 33745 0
Contact person for public queries
Name 16992 0
Dr. Char Meng Chuor
Address 16992 0
National Centre for Parasitology, Entomology and Malaria Control
#372 Monivong Blvd, Phnom Penh Cambodia
Country 16992 0
Cambodia
Phone 16992 0
855 12 841168
Fax 16992 0
Email 16992 0
[email protected]
Contact person for scientific queries
Name 7920 0
Steven Bjorge
Address 7920 0
World Health Organization Office of the Representative to Cambodia
#177-179 Corner Streets Pasteur (51) and 254, Sangkat Chak Tomouk, Khan Daun Penh, Phnom Penh
Country 7920 0
Cambodia
Phone 7920 0
(855) 12666431
Fax 7920 0
Email 7920 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.