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 | https://doi.org/10.1186/ISRCTN64793756 |
| Secondary identifying numbers | SCC 1025 |
- Submission date
- 17/05/2006
- Registration date
- 08/08/2006
- Last edited
- 27/04/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michael Walther
Scientific
Scientific
Malaria Programme
Medical Research Council Laboratories
Atlantic Boulevard
Fajara
P.O.Box 273
Gambia
| Phone | +220 4497928, 4495442/6 Ext 338 |
|---|---|
| mwalther@mrc.gm |
Study information
| 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 |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | In mice, oral administration of activated charcoal improves survival in Lipopolysaccharide (LPS)-induced endotoxemia, during sepsis and cerebral malaria. |
| Ethics approval(s) | Approved by Gambian government/Medical Research Council Laboratories Joint Ethics Committee on 23 December 2005. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Activated charcoal, artesunate |
| Primary outcome measure | Impact of oral activated charcoal on the pharmacokinetics of parenteral artesunate. |
| Secondary outcome measures | Reduced parasite clearance of i.v. artesunate |
| Overall study start date | 29/05/2006 |
| Completion date | 29/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 90 |
| Key inclusion criteria | Healthy African adults aged 15-45 years with asymptomatic parasitaemia confirmed on a thick blood film. |
| Key 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 |
| Date of first enrolment | 29/05/2006 |
| Date of final enrolment | 29/10/2006 |
Locations
Countries of recruitment
- Gambia
Study participating centre
Malaria Programme
Fajara
P.O.Box 273
Gambia
P.O.Box 273
Gambia
Sponsor information
Medical Research Council (MRC) (UK)
Government
Government
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0) 2076 365422 |
|---|---|
| corporate@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
"ROR" |
https://ror.org/03x94j517 |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/04/2010 | Yes | No |
