Condition category
Infections and Infestations
Date applied
21/05/2010
Date assigned
24/06/2010
Last edited
24/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mayfong Mayxay

ORCID ID

Contact details

Microbiology Laboratory
Mahosot Hospital
Vientiane Captial
100
Laos

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Clinical investigation of in-vivo susceptibility of Plasmodium falciparum to artesunate in Xepon Inter-District Hospital, Savannakhet Province, Laos

Acronym

Anredaud

Study hypothesis

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

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)

Study design

Open randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Artesunate, artemether-lumefantrine

Primary outcome measures

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 trial start date

01/06/2010

Overall trial end date

01/10/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

01/06/2010

Recruitment end date

01/10/2010

Locations

Countries of recruitment

Laos

Trial participating centre

Microbiology Laboratory
Vientiane Captial
100
Laos

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Churchill Hospital
CCVTM
Headington
Oxford
OX3 7LJ
United Kingdom

Sponsor type

University/education

Website

http://www.jr2.ox.ac.uk/ndm/Tropical_Medicine

Funders

Funder type

Research organisation

Funder name

World Health Organization (WHO) (Switzerland)

Alternative name(s)

WHO

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

Switzerland

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes