Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000183886
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
Efficacy and safety of dihydroartemisinin-piperaquine (DP) in Pailin, Preah Vihear and Rattanakiri, and artesunate-mefloquine (ASMQ) in Preah Vihear for uncomplicated P. falciparum malaria and chloroquine (CQ) for P.vivax malaria in the above 3 sites, Cambodia, 2009
Scientific title
Efficacy and safety of dihydroartemisinin-piperaquine (DP) in Pailin, Preah Vihear and Rattanakiri, and artesunate-mefloquine (ASMQ) in Preah Vihear for uncomplicated P. falciparum malaria and chloroquine (CQ) for P.vivax malaria in the above 3 sites, Cambodia, 2009
Secondary ID [1] 279892 0
Nil
Universal Trial Number (UTN)
U1111-1128-0194
Trial acronym
TESCAM09
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 285793 0
Condition category
Condition code
Infection 285971 285971 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Drugs were dihydroartemisinin-piperaquine (DP), artesunate-mefloquine (ASMQ) and Chloroquine (CQ). One group was treated with DP daily over 3 days, and another group was treated with ASMQ daily over 3 days for uncomplicated Plasmodium falciparum malaria. In a separate group of patients with P. vivax malaria, CQ alone was used for treatment.

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

CQ (oral tablet) at 10mg/kg on Day1, 10mg/kg on Day2 and 5 mg/kg on Day3 based on the weight group
Intervention code [1] 284215 0
Treatment: Drugs
Comparator / control treatment
No control and comparator group. This was a single group trial. In falciparum infected patients in Preah Vihear, DP was tested first and when it was finished ASMQ was tested for another group of patients, in Pailin and Rattanakiri only DP was tested. In a separate group of vivax infected patients, CQ was tested in the three sites.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286469 0
42-day cure rate or ACPR (adequate clinical and parasitological response for falciparum cases and 28-day for vivax.

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] 286469 0
at the end of 42-day follow up for falciparum cases and end of 28 days for vivax cases
Secondary outcome [1] 295943 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] 295943 0
first 3 days after drug administration

Eligibility
Key inclusion criteria
-Above 1 year old;
-Mono Infection with P. falciparum or P. vivax;
-Parasitaemia, 1000–200 000 asexual forms per microlitre for P.f and above 250 asexual forms per microlitre for P.v ;
-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
1 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-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
Completed
Date of first participant enrolment
Anticipated
1/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
420
Accrual to date
Final
Recruitment outside Australia
Country [1] 4111 0
Cambodia
State/province [1] 4111 0
Pailin
Country [2] 4112 0
Cambodia
State/province [2] 4112 0
Preah Vihear
Country [3] 4113 0
Cambodia
State/province [3] 4113 0
Rattanakiri

Funding & Sponsors
Funding source category [1] 284661 0
Other
Name [1] 284661 0
WHO
Country [1] 284661 0
Philippines
Funding source category [2] 284662 0
Other
Name [2] 284662 0
Global Fund For Malaria
Country [2] 284662 0
Cambodia
Primary sponsor type
Other
Name
Institude Paster du Cambodge
Address
Monivong Blvd, Phnom Penh Cambodia
Country
Cambodia
Secondary sponsor category [1] 283567 0
None
Name [1] 283567 0
Address [1] 283567 0
Country [1] 283567 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This study was a one-arm prospective evaluation of the clinical and parasitological responses to directly observed treatment for uncomplicated falciparum and vivax malaria. The objective was to assess the efficacy and safety of dihydroartemisinin-piperaquine (DP) and artesunate-mefloquine (ASMQ) for the treatment of uncomplicated Plasmodium falciparum malaria in Preah Vihear and only DP in Pailin and Rattanakiri provinces, and Chloroquine (CQ) in these three sites in Cambodia. The WHO 28-day and 42-day in vivo protocol was used. Patients with uncomplicated P.f or P.v malaria who met the study inclusion criteria were enrolled and treated on site with DP or ASMQ or CQ and monitored weekly for 28 days for P.v cases and 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 P. f and P.v malaria.
Trial website
Nil
Trial related presentations / publications
Presentations in Cambodia during the annual report workshop organized by the National Centre for Parasitology, Entomology and Malaria Control in 2009
Public notes

Contacts
Principal investigator
Name 33744 0
Address 33744 0
Country 33744 0
Phone 33744 0
Fax 33744 0
Email 33744 0
Contact person for public queries
Name 16991 0
Dr. Char Meng Chuor
Address 16991 0
National Centre for Parasitology, Entomology and Malaria Control
#372 Monivong Blvd, Phnom Penh
Country 16991 0
Cambodia
Phone 16991 0
855 12 841168
Fax 16991 0
Email 16991 0
mengchuor@gmail.com
Contact person for scientific queries
Name 7919 0
Steven Bijorge
Address 7919 0
World Health Organization Office to representative of Cambodia
#177-179 Corner Streets Pasteur (51) and 254, Sangkat Chak Tomouk, Khan Daun Penh, Phnom Penh, Cambodia
Country 7919 0
Cambodia
Phone 7919 0
(855) 23 216610, 216942, 212228
Fax 7919 0
Email 7919 0
bjorges@wpro.who.int

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

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