Condition category
Infections and Infestations
Date applied
17/05/2006
Date assigned
08/08/2006
Last edited
27/04/2010
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 Michael Walther

ORCID ID

Contact details

Malaria Programme
Medical Research Council Laboratories
Atlantic Boulevard
Fajara
P.O.Box 273
Gambia
+220 4497928, 4495442/6 Ext 338
mwalther@mrc.gm

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SCC 1025

Study information

Scientific title

Acronym

Study hypothesis

In mice, oral administration of activated charcoal improves survival in Lipopolysaccharide (LPS)-induced endotoxemia, during sepsis and cerebral malaria.

Ethics approval

Approved by Gambian government/Medical Research Council Laboratories Joint Ethics Committee on 23 December 2005.

Study design

Open labelled randomised, non-blinded controlled population based pharmacokinetic study (phase I study)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Asymptomatic parasitaemia for Plasmodium falciparum

Intervention

Co-administration of oral activated charcoal and intravenous (i.v.) artesunate to study participants randomised into three groups as follows:
Group one (control): i.v. artesunate without adjuvant treatment, plus 350 mls of water given orally with each i.v. dose
Group two: i.v. artesunate with simultaneous administration of oral activated charcoal (50 g) with each dose of artesunate
Group three: i.v. artesunate followed by oral activated charcoal (50 g) given one hour after each dose of artesunate.

All subjects will receive 2.4 mg/kg of i.v. artesunate at zero, 12 and 24 hours. To avoid recrudescence, the study participants will receive a full course of Co-artem (four tablets twice daily for three days) used as a follow-on therapy starting 72 hours after the first dose of i.v. artesunate.

Intervention type

Drug

Phase

Phase I

Drug names

Activated charcoal, artesunate

Primary outcome measures

Impact of oral activated charcoal on the pharmacokinetics of parenteral artesunate.

Secondary outcome measures

Reduced parasite clearance of i.v. artesunate

Overall trial start date

29/05/2006

Overall trial end date

29/10/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy African adults aged 15-45 years with asymptomatic parasitaemia confirmed on a thick blood film.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant exclusion criteria

1. Haemoglobin less than 11 g/dl
2. Detectable levels of chloroquine in the urine
3. Mixed infections
4. Concurrent participation in another study
5. Pregnant or breastfeeding

Recruitment start date

29/05/2006

Recruitment end date

29/10/2006

Locations

Countries of recruitment

Gambia

Trial participating centre

Malaria Programme
Fajara
P.O.Box 273
Gambia

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0) 2076 365422
corporate@headoffice.mrc.ac.uk

Sponsor type

Government

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20419161

Publication citations

  1. Results

    de Souza JB, Okomo U, Alexander ND, Aziz N, Owens BM, Kaur H, Jasseh M, Muangnoicharoen S, Sumariwalla PF, Warhurst DC, Ward SA, Conway DJ, Ulloa L, Tracey KJ, Foxwell BM, Kaye PM, Walther M, Oral activated charcoal prevents experimental cerebral malaria in mice and in a randomized controlled clinical trial in man did not interfere with the pharmacokinetics of parenteral artesunate., PLoS ONE, 2010, 5, 4, e9867, doi: 10.1371/journal.pone.0009867.

Additional files

Editorial Notes