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 |
| Protocol serial number | SCC 1025 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Open labelled randomised, non-blinded controlled population based pharmacokinetic study (phase I study) |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Activated charcoal, artesunate |
| Primary outcome measure(s) |
Impact of oral activated charcoal on the pharmacokinetics of parenteral artesunate. |
| Key secondary outcome measure(s) |
Reduced parasite clearance of i.v. artesunate |
| Completion date | 29/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
