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Trial registered on ANZCTR


Registration number
ACTRN12612000181808
Ethics application status
Approved
Date submitted
18/02/2011
Date registered
10/02/2012
Date last updated
10/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety study of dihydroarteminisinin-piperaquine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria and dihydroartemisinin-piperaquine for plasmodium vivax treatment in Ochra Health Centre (Pailin Province), Promoy Health Centre (Pursat Province), and in Veunsai Health Centre (Rattanakiri province), Cambodia 2010
Scientific title
Efficacy and safety study of dihydroarteminisinin-piperaquine and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria and dihydroartemisinin-piperaquine for plasmodium vivax treatment in Ochra Health Centre (Pailin Province), Promoy Health Centre (Pursat Province), and in Veunsai Health Centre (Rattanakiri province), Cambodia 2010
Secondary ID [1] 259639 0
Nil
Universal Trial Number (UTN)
U1111-1127-9876
Trial acronym
TESCAM2010
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 261205 0
Condition category
Condition code
Infection 286001 286001 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Drugs are dihydroartemisinin-piperaquine (DP) and artemether-lumefantrine (AL). One group was treated with Artemether-lumefantrine (AL) over 3 days and another group is treated with dihydroartemisinin-piperaquine (DP) over 3 days for Plasmodium falciparum malaria. In a separate group of patients with P. vivax malaria, DP was also used for treatment.

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

AL (oral tablet) 1.4-4 mg/kg of A and 10-16 mg/kg of L daily over 3 days based on weight band
Intervention code [1] 258071 0
Treatment: Drugs
Comparator / control treatment
No control and comparator group. This is a single group trial. In falciparum infected patients, DP was tested in Pailin and Veal Veng sites, and AL was tested in Rattanakiri site. In a separate group of vivax infected patients, DP was tested in Pailin, Veal veng and Rattanakiri sites.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262168 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] 262168 0
at the end of 42-day follow up for falciparum cases and end of 28 days for vivax cases.
Secondary outcome [1] 273264 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] 273264 0
first 3 days of drug administration

Eligibility
Key inclusion criteria
-Above 2years old (all age groups);
-Mono Infection with P. falciparum or P. vivax;
-Parasitaemia, 2000–200 000 asexual forms per microlitre ;
-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
45 Years
Gender
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 Plasmodium 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
Nil
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / 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] 3211 0
Cambodia
State/province [1] 3211 0
Palin
Country [2] 3212 0
Cambodia
State/province [2] 3212 0
Pursat
Country [3] 3213 0
Cambodia
State/province [3] 3213 0
Rattanakiri

Funding & Sponsors
Funding source category [1] 258571 0
Other
Name [1] 258571 0
WHO
Address [1] 258571 0
World Health Organization Regional Office for the Western Pacific, UN Avenue, Manila 1000 Philippines
Country [1] 258571 0
Philippines
Funding source category [2] 284656 0
Other
Name [2] 284656 0
Global Fund For Malaria
Address [2] 284656 0
# 372 Monivong Blvd, Phnom Penh, Cambodia
Country [2] 284656 0
Cambodia
Primary sponsor type
Government body
Name
National Centre for Malaria Control
Address
#372 Monivong Blvd, Phnom Penh Cambodia
Country
Cambodia
Secondary sponsor category [1] 257670 0
None
Name [1] 257670 0
Address [1] 257670 0
Country [1] 257670 0
Other collaborator category [1] 251823 0
Other
Name [1] 251823 0
Institude Paster du Cambodge
Address [1] 251823 0
Monivong Blvd, Phnom Penh Cambodia
Country [1] 251823 0
Cambodia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260504 0
National Ethics Comittee for Health Research
Ethics committee address [1] 260504 0
#2 Kim YL Sung Blvd, Khan Tuol Kok, Phnom Penh, Cambodia
Ethics committee country [1] 260504 0
Cambodia
Date submitted for ethics approval [1] 260504 0
30/04/2010
Approval date [1] 260504 0
23/06/2010
Ethics approval number [1] 260504 0
101 NECHR

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 is to assess the efficacy and safety of dihydroartemisinin-piperaquine (DP) and artemether-lumefantrine (AL) for the treatment of uncomplicated Plasmodium falciparum malaria in 3 sites Pailin, Pursat and Rattanakiri provinces, Cambodia. The WHO 28-day and 42-day in vivo protocol was used. Patients with uncomplicated P.f or P.v malaria who meet the study inclusion criteria were enrolled and treated on site with DP or AL 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 April 2010

Drug policy consensus meeting in Phnom Penh in November 2010
Public notes

Contacts
Principal investigator
Name 32240 0
Address 32240 0
Country 32240 0
Phone 32240 0
Fax 32240 0
Email 32240 0
Contact person for public queries
Name 15487 0
Dr. Char Meng Chuor
Address 15487 0
National Centre for Parasitology, Entomology and Malaria Control
#372 Monivong Blvd, Phnom Penh Cambodia
Country 15487 0
Cambodia
Phone 15487 0
855 12 841168
Fax 15487 0
855 23 996 202
Email 15487 0
mengchuor@gmail.com
Contact person for scientific queries
Name 6415 0
Steven Bijorge
Address 6415 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 6415 0
Cambodia
Phone 6415 0
(855) 23 216610, 216942, 212228
Fax 6415 0
Email 6415 0
bjorges@wpro.who.int

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