Is there any evidence of antimalarial resistance to artemisinin derivatives in southern Laos?

ISRCTN	ISRCTN12741594
DOI	https://doi.org/10.1186/ISRCTN12741594
Secondary identifying numbers	N/A

Submission date: 21/05/2010
Registration date: 24/06/2010
Last edited: 24/06/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mayfong Mayxay
Scientific

Microbiology Laboratory
Mahosot Hospital
Vientiane Captial
100
Lao People's Democratic Republic

Study information

Study design	Open randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Clinical investigation of in-vivo susceptibility of Plasmodium falciparum to artesunate in Xepon Inter-District Hospital, Savannakhet Province, Laos
Study acronym	Anredaud
Study objectives	The parasite clearance times (PCT) and the efficacy after 2 mg/kg and 4 mg/kg oral artesunate, followed by 3-days artemether-lumefantrine, are not prolonged.
Ethics approval(s)	1. Oxford Tropical Research Ethics Committee (UK) approved on the 8th June 2009 (ref: OXTREC 29-09) 2. Lao PDR National Ethics Committee for Health Research (NECHR) approved on the 18th May 2009 (Ref: 246/NECHR)
Health condition(s) or problem(s) studied	Plasmodium falciparum malaria, antimalarial drugs
Intervention	Treatment arm 1: oral artesunate 2 mg/kg/day for 3 days followed by oral artemether-lumefantrine (20/120 mg): 1 dose twice daily for three days. Dosing by body weight will be: 1 tablet if less than 15 kg, 2 tablets if 15 - 24 kg, 3 tablets if 25 - 34 kg, and 4 tablets if greater than 35 kg. Treatment arm 2: oral artesunate 4 mg/kg/day for 3 days followed by oral artemether-lumefantrine (20/120 mg): 1 dose twice daily for three days. Dosing by body weight will be: 1 tablet if less than 15 kg, 2 tablets if 15 - 24 kg, 3 tablets if 25 - 34 kg, and 4 tablets if greater than 35 kg. The duration of follow-up for both arms is 42 days.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Artesunate, artemether-lumefantrine
Primary outcome measure	Number of patients with PCT greater than 72 hours. If six or more patients per treatment group (n = 20) have PCTs greater than 72 hours the trial will be stopped.
Secondary outcome measures	To assess the efficacy of artesunate 2 mg/kg/day and 4 mg/kg/day followed by 3-days artemether-lumefantrine in the treatment of uncomplicated P. falciparum malaria after 42-days follow up. Assessed on the basis of an assessment of the parasitological and clinical outcome of antimalarial treatment according to the latest WHO guidelines.
Overall study start date	01/06/2010
Completion date	01/10/2010

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	40
Key inclusion criteria	1. Male and female, aged greater than 10 years 2. Female patients between ages of 10 and 12 years old, provided they have not reached menarche, and those who have passed through the menopause 3. Mono-infection with P. falciparum as detected by microscopy 4. Parasitaemia of 10,000 - 175,000/µl asexual forms 5. Presence of axillary or tympanic temperature greater than or equal to 37.5°C or oral or rectal temperature of greater than or equal to 38°C or history of fever during the past 24 hours 6. Ability to swallow oral medication 7. Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule 8. Informed consent from the patient or from a parent or guardian in the case of children
Key exclusion criteria	1. Presence of general danger signs or severe falciparum malaria according to the definitions of the World Health Organization (WHO, 2000) 2. Mixed or mono-infection with another Plasmodium species detected by microscopy 3. Presence of severe malnutrition (defined as a child whose growth standard is below -3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference less than 110 mm) 4. Presence of febrile conditions due to diseases other than malaria or other known underlying chronic or severe diseases 5. Regular medication, which may interfere with antimalarial pharmacokinetics 6. Received antimalarial drugs in the previous 48 hours 7. History of hypersensitivity reactions or contraindications to any of the medicine(s) used 8. Female patients of child-bearing age, defined as those who menstruate or are aged over 12 years and have not reached the menopause 9. Breastfeeding 10. Splenectomy
Date of first enrolment	01/06/2010
Date of final enrolment	01/10/2010

Locations

Countries of recruitment

Lao People's Democratic Republic

Study participating centre

Microbiology Laboratory

Vientiane Captial
100
Lao People's Democratic Republic

Sponsor information

University of Oxford (UK)
University/education

Churchill Hospital
CCVTM
Headington
Oxford
OX3 7LJ
England
United Kingdom

Website	http://www.jr2.ox.ac.uk/ndm/Tropical_Medicine
"ROR"	https://ror.org/052gg0110

Funders

Funder type

Research organisation

World Health Organization (WHO) (Switzerland)
Private sector organisation / International organizations

Alternative name(s): منظمة الصحة العالمية, 世界卫生组织, Всемирная организация здравоохранения, Organisation mondiale de la Santé, Organización Mundial de la Salud, WHO, 世卫组织, ВОЗ, OMS
Location: Switzerland

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan