ANZCTR - Registration

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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

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1127-9876

Trial acronym

TESCAM2010

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Malaria

Condition category

Condition code

Infection

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]

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]

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]

at the end of 42-day follow up for falciparum cases and end of 28 days for vivax cases.

Secondary outcome [1]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

6/08/2010

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]

Cambodia

State/province [1]

Palin

Country [2]

Cambodia

State/province [2]

Pursat

Country [3]

Cambodia

State/province [3]

Rattanakiri

Funding & Sponsors

Funding source category [1]

Other

Name [1]

WHO

Address [1]

World Health Organization Regional Office for the Western Pacific, UN Avenue, Manila 1000 Philippines

Country [1]

Philippines

Funding source category [2]

Other

Name [2]

Global Fund For Malaria

Address [2]

# 372 Monivong Blvd, Phnom Penh, Cambodia

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Other

Name [1]

Institude Paster du Cambodge

Address [1]

Monivong Blvd, Phnom Penh Cambodia

Country [1]

Cambodia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

National Ethics Comittee for Health Research

Ethics committee address [1]

#2 Kim YL Sung Blvd, Khan Tuol Kok, Phnom Penh, Cambodia

Ethics committee country [1]

Cambodia

Date submitted for ethics approval [1]

30/04/2010

Approval date [1]

23/06/2010

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr. Char Meng Chuor

Address

National Centre for Parasitology, Entomology and Malaria Control
#372 Monivong Blvd, Phnom Penh Cambodia

Country

Cambodia

Phone

855 12 841168

Fax

855 23 996 202

mengchuor@gmail.com

Contact person for scientific queries

Name

Steven Bijorge

Address

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

Cambodia

Phone

(855) 23 216610, 216942, 212228

Fax

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A surrogate marker of piperaquine-resistant Plasmodium falciparum malaria: a phenotype-genotype association study.	2017	https://dx.doi.org/10.1016/S1473-3099%2816%2930415-7

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically