Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03326492 |
| Other study ID # |
2016-092 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 17, 2019 |
| Est. completion date |
September 14, 2021 |
Study information
| Verified date |
February 2022 |
| Source |
Institut Pasteur |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
There is little or no assessment under real-use conditions of the efficacy and the tolerance
in the short, medium and long term of the antivenoms currently on the market and used in the
treatment of snake bites.
The main objective is to assess the short term tolerance (< 2 hours post-injection) of the
antivenom Inoserp Pan-Africa® (temporary market authorization) from Inosan laboratory
currently available in Cameroon.
Description:
Globally, the number of annual envenomings is estimated to be between 420,000 and 1,800,000.
In sub-Saharan Africa, the annual number of envenomings is estimated at 315,000, leading to
more than 9,000 amputations and about 7,000 deaths.
Snake bites are recognized by many authors as a neglected disease, whose incidence is
underestimated or even unknown in several countries of sub-Saharan Africa. Few data are
currently available on the morbidity, mortality and economic impact of snake bites.
In Cameroon and particularly in the northern part of the country, where the density of snakes
is high, a few studies have been carried out. In 2002, the annual incidence of envenomings
was estimated at 200/100 000 inhabitants, of which 85% was due to Echis ocellatus, and the
lethality was 23.9% in some centers. The Ministry of Public Health introduced snake bites in
2015 as a priority health problem in the list of diseases being monitored. Thus, a national
epidemiological surveillance system, with a weekly count of snake bites, has been
implemented. In the first year, the incidence of annual snake bites was 11.4/100,000
inhabitants, representing more than 2,500 bites per year, including 43 deaths and a case
fatality rate of up to 6% in some areas. The northern region (Adamaoua, North and Far North
regions) (savanna and mixed zone) accounts for 40% of the country's burden and 77% of the
deadly burden, while the forest zone accounts for 32% of the burden Morbid disease and 16% of
the fatal burden (ministerial source). The monitoring is based on paper registers for bite
reporting, supplemented by the sending of pharmacovigilance data by text messages, but this
is very little used in current practice. The data collection system in Cameroon could
therefore be improved in terms of both completeness and speed of centralizing data.
These estimates are likely to be well below the reality given the non-exhaustive nature of
the data collection and the frequent use of traditional practitioners without referral in a
hospital structure.
In recent years, FAV-Afrique® produced by Sanofi-Pasteur was the treatment of reference for
venomous snake bites in West and Central Africa. It was the most evaluated and the most
effective, reducing by a factor 5 to 10 the mortality. This anti-venom serum was
polyspecific, containing an antivenom against ten species of snakes: Naja melanoleuca,
nigricollis & haje; Dendroaspis polylepis, viridis & jamesoni, Bitis gabonica & arietans;
Echis leucogaster & ocellatus.
However, Sanofi-Pasteur stopped production (last batch produced in January 2014 and expired
in June 2016), making it necessary to use other snake antivenoms. Since the end of 2015, two
new antivenoms are available in Cameroon where they are granted a provisional marketing
authorization. Few clinical trials have evaluated the antivenoms currently available in
Africa.
Some clinical efficacy and safety data have been published for Inoserp Pan-Africa®. However,
the number of subjects was limited and assessment was limited to the period of
hospitalization.
The lack of sufficient data on incidence and mortality associated with snake bites, the
current weakness of the epidemiological data collection system and the presence on the market
of antivenoms that are very little evaluated in terms of tolerance, effectiveness make action
necessary.
The main objective of the study is therefore to assess the tolerance and the efficacy of the
antivenom Inoserp Pan-Africa® from Inosan laboratory currently available in Cameroon.This
study will be conducted under routine conditions in order to avoid bias in the results
through the implementation of dedicated logistics which would not be representative of the
usual conditions.
