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Evaluating the potential role of oral activated charcoal as an adjunct treatment for severe bacterial infections and severe malaria - a preliminary safety study
ISRCTN ISRCTN64793756
DOI 10.1186/ISRCTN64793756
ClinicalTrials.gov identifier
EudraCT number
Public title Evaluating the potential role of oral activated charcoal as an adjunct treatment for severe bacterial infections and severe malaria - a preliminary safety study
Scientific title
Acronym N/A
Serial number at source SCC 1025
Study hypothesis In mice, oral administration of activated charcoal improves survival in Lipopolysaccharide (LPS)-induced endotoxemia, during sepsis and cerebral malaria.
Lay summary
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)
Countries of recruitment Gambia
Disease/condition/study domain Asymptomatic parasitaemia for Plasmodium falciparum
Participants - inclusion criteria Healthy African adults aged 15-45 years with asymptomatic parasitaemia confirmed on a thick blood film.
Participants - 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
Anticipated start date 29/05/2006
Anticipated end date 29/10/2006
Status of trial Completed
Patient information material
Target number of participants 90
Interventions 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.
Primary outcome measure(s) Impact of oral activated charcoal on the pharmacokinetics of parenteral artesunate.
Secondary outcome measure(s) Reduced parasite clearance of i.v. artesunate
Sources of funding Medical Research Council (MRC) (UK)
Trial website
Publications 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20419161
Contact name Dr  Michael  Walther
  Address Malaria Programme
Medical Research Council Laboratories
Atlantic Boulevard
  City/town Fajara
  Zip/Postcode P.O.Box 273
  Country Gambia
  Tel +220 4497928, 4495442/6 Ext 338
  Fax +220 4496513
  Email mwalther@mrc.gm
Sponsor Medical Research Council (MRC) (UK)
  Address 20 Park Crescent
  City/town London
  Zip/Postcode W1B 1AL
  Country United Kingdom
  Tel +44 (0) 2076 365422
  Fax +44 (0) 2074 366179
  Email corporate@headoffice.mrc.ac.uk
  Sponsor website: http://www.mrc.ac.uk
Date applied 17/05/2006
Last edited 27/04/2010
Date ISRCTN assigned 08/08/2006
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