Clinical trial of two new anti-snake venoms for the treatment of patients bitten by venomous snakes in Nigeria
| ISRCTN | ISRCTN01257358 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01257358 |
| Secondary identifying numbers | EC003/05 |
- Submission date
- 13/01/2009
- Registration date
- 18/02/2009
- Last edited
- 30/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Isa Sadeeq Abubakar
Scientific
Scientific
Department of Community Medicine
Bayero University Kano
Kano
700001
Nigeria
Study information
| Study design | Randomised controlled double blind non-inferiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Pre-clinical and clinical assessment of new anti-venoms for the treatments of patients envenomed by the saw-scaled or carpet viper (Echis ocellatus) in northern Nigeria |
| Study acronym | ECGECP |
| Study objectives | EchiTAb™ G and EchiTAb™ Plus have similar efficacy and safety profiles with South African Institute for Medical Research (SAIMR) anti-venom (Gold standard) in restoration of coagulation after envenomation from the bite of Echis ocellatus. Please note that as of 11/02/10 the primary outcome field of this trial have been updated. Please view the relevant field for more details. |
| Ethics approval(s) | 1. National Agency for Food and Drug Adminstration and Control (NAFDAC), Nigeria, gave approval on the 12th February 2005 2. Gombe State Governmental Medical Research Ethical Committee gave approval on the 8th March 2005 (ref: MOH/ADM/S/909/V.I/11) |
| Health condition(s) or problem(s) studied | Snake bite |
| Intervention | EchiTAb™ Plus is produced by the Instituto Clodomiro Picado (ICP), University of Costa Rica in collaboration with the EchiTAb study group Nigeria/UK and Liverpool School of Tropical Medicine and University of Oxford. This is an equine trispecific anti-venom raised against the venoms of Nigerian E. ocellatus, Bitis arietans (puff adder) and Naja nigricollis (spitting cobra). These venoms were selected because, from a medical point of view, they are the three most important snake species in sub-Saharan Africa. The anti-venom is prepared by caprylic acid precipitation of non-IgG plasma proteins. Preclinical tests using WHO-approved methods showed these antivenoms to be as effective or almost as effective against E. ocellatus venom as the original ovine Fab fragment monospecific EchiTAb™. The final product is presented as a liquid in 10 ml vials with a 3 year expiry period. 30 ml EchiTAb™ Plus will be given to each participant. EchiTAb™ G, which was developed and produced by EchiTAb study group Nigeria/UK, in collaboration with Micropharm Ltd UK and Liverpool School School of Tropical Medicine and Hygiene, is a purified IgG prepared by caprylic acid precipitation of non-IgG plasma proteins similar to the Costa Rican anti-venom described above. The final preparation is a liquid 10 ml vial with a 3-year expiry time. 10 ml EchiTAb™ G will be given to each participant. Both anti-venoms are given through the intravenous route slowly (at the rate of 2 ml/minute). To ensure blinding however, sterile water is drawn into the syringe by the Hospital Pharmacist (who is not part of the research team) to making up to 40 ml of a mixture of anti-venom and sterile water. Once a patient has been enrolled into the study and allocated to one of the two treatment groups, 20-minute Whole Blood Clotting Time (20WBCT) test is done to establish coagulopathy. Once established, the anti-venom is given, six hours after which the 20WBCT is repeated to establish whether or not coagulation is restored. If restored, no anti-venom is given, but the same test is repeated 6-hourly for 48 hours, and the patient subsequently discharged if coagulation is sustained. However, in a situation where the blood during the 20WBCT after administration of anti-venom does not clot, a repeat dose of the anti-venom is given and the same process followed until coagulation is sustained for up to 48 hours. Note that immediately after administration of the anti-venom, observation is made for signs of early anaphylactic or pyrogenic reactions. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | EchiTAb™ G anti-venom, EchiTAb™ Plus anti-venom, South African Institute for Medical Research (SAIMR) anti-venom |
| Primary outcome measure | Current information as of 11/02/10: Restoration of blood coagulability, measured 6 hours after the initial dose of antivenom is deemed the primary outcome and time point of main interest. Incoagulable blood, measured at baseline, is an eligibility criterion. To ensure that restoration of blood coagulability at 6 hr is not transient followed by recurrent envenoming, it is also checked at 12, 18, 24 and 48 hours after the initial dose of antivenom. Initial information at time of registration: Blood coagulability, measured at baseline, 6, 12, 18, 24 and 48 hours after treatment |
| Secondary outcome measures | 1. Anaphylactic reaction, measured immediately after treatment with anti-venom 2. Pyrogenic reaction, measured immediately after treatment with anti-venom 3. Late serum sickness, measured 2 weeks after discharge |
| Overall study start date | 14/05/2005 |
| Completion date | 28/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 400 |
| Total final enrolment | 400 |
| Key inclusion criteria | Patients of both sexes and all ages bitten by snakes provided that: 1. They had incoagulable blood as defined by 20 minutes whole blood clotting time, indicative in this area of systemic envenoming by E. ocellatus 2. They have been bitten within the previous 72 hours 3. They or their relatives give informed consent to admission, treatment and investigation |
| Key exclusion criteria | 1. Patients who had received antisnake venom within the last 24 hours 2. Pregnant women 3. Patients with clinical features of severe envenoming (shock, massive bleeding, lateralising signs suggesting intracranial haemorrhage, etc.) who require urgent treatment with a large dose of anti-venom and resuscitation |
| Date of first enrolment | 14/05/2005 |
| Date of final enrolment | 28/12/2008 |
Locations
Countries of recruitment
- Nigeria
Study participating centre
Department of Community Medicine
Kano
700001
Nigeria
700001
Nigeria
Sponsor information
Federal Ministry of Health (Nigeria)
Government
Government
Directorate of Special Project
Federal Secretariat Complex
Abuja
800001
Nigeria
| Website | http://www.fmhng.org/ |
|---|---|
"ROR" |
https://ror.org/02v6nd536 |
Funders
Funder type
Government
Federal Ministry of Health (Nigeria)
No information available
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 | 27/07/2010 | 30/12/2020 | Yes | No |
Editorial Notes
30/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
