Snake Bites Clinical Trial
— RADIANSOfficial title:
Routine vs. Clinically-Directed Antibiotic Treatment in Snake Bite With Local Envenomation: a Randomised Controlled Trial
Verified date | April 2024 |
Source | Jawaharlal Institute of Postgraduate Medical Education & Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Clinicians tend to overuse antibiotics in snake bite despite evidence from three previous clinical trials that failed to show a benefit. But, none of these trials was done in India. Further, the species of snake in two of these trials was quite different from that seen in the Indian setting limiting generalization of these findings. Hence, home-grown evidence is needed to persuade clinicians to use antibiotics rationally.
Status | Terminated |
Enrollment | 66 |
Est. completion date | March 31, 2020 |
Est. primary completion date | October 24, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Age 18-65 years - History of snake bite with features of local envenomation with/without systemic features - Less than 24 hours since bite, AND - No prior antibiotic treatment Exclusion Criteria: - Upper limb bites - Multiple (> 1) bites - Wound manipulation - Extensive local necrosis or blebs - Seriously-ill patients with hypotension/capillary leak/life threatening bleeding. - Suspected cobra bite, OR - Pregnant/breast-feeding women |
Country | Name | City | State |
---|---|---|---|
India | Department of Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research | Pondicherry | Puducherry |
Lead Sponsor | Collaborator |
---|---|
Jawaharlal Institute of Postgraduate Medical Education & Research |
India,
Jorge MT, Malaque C, Ribeiro LA, Fan HW, Cardoso JL, Nishioka SA, Sano-Martins IS, Franca FO, Kamiguti AS, Theakston RD, Warrell DA. Failure of chloramphenicol prophylaxis to reduce the frequency of abscess formation as a complication of envenoming by Bothrops snakes in Brazil: a double-blind randomized controlled trial. Trans R Soc Trop Med Hyg. 2004 Sep;98(9):529-34. doi: 10.1016/j.trstmh.2003.12.009. — View Citation
Kerrigan KR, Mertz BL, Nelson SJ, Dye JD. Antibiotic prophylaxis for pit viper envenomation: prospective, controlled trial. World J Surg. 1997 May;21(4):369-72; discussion 372-3. doi: 10.1007/pl00012255. — View Citation
Kularatne SA, Kumarasiri PV, Pushpakumara SK, Dissanayaka WP, Ariyasena H, Gawarammana IB, Senanayake N. Routine antibiotic therapy in the management of the local inflammatory swelling in venomous snakebites: results of a placebo-controlled study. Ceylon Med J. 2005 Dec;50(4):151-5. doi: 10.4038/cmj.v50i4.1405. — View Citation
Mohapatra B, Warrell DA, Suraweera W, Bhatia P, Dhingra N, Jotkar RM, Rodriguez PS, Mishra K, Whitaker R, Jha P; Million Death Study Collaborators. Snakebite mortality in India: a nationally representative mortality survey. PLoS Negl Trop Dis. 2011 Apr 12;5(4):e1018. doi: 10.1371/journal.pntd.0001018. — View Citation
Terry P, Mackway-Jones K. Towards evidence based emergency medicine: best BETs from the Manchester Royal Infirmary. Antibiotics in non-venomous snakebite. Emerg Med J. 2002 Mar;19(2):142. doi: 10.1136/emj.19.2.142. — View Citation
Terry P, Mackway-Jones K. Towards evidence based emergency medicine: best BETs from the Manchester Royal Infirmary. The use of antibiotics in venomous snake bite. Emerg Med J. 2002 Jan;19(1):48-9. doi: 10.1136/emj.19.1.48. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical failure | Defined as occurrence of any one of the following on daily assessments - Abscess formation at any point of time; Surgical debridement/fasciotomy at any time; Worsening limb swelling beyond 72-96 hours or appearance of necrosis or blebs along with any one of the following: fever, persistent or worsening leucocytosis, or global deterioration on clinical assessment. | up to 4 weeks | |
Primary | Antibiotic consumption | Defined as the total amount of all antibiotics consumed regardless of clinical indication expressed in terms of defined daily doses (DDD). | up to 4 weeks | |
Secondary | Length of hospital stay | Number of days from hospital admission until discharge | up to 4 weeks | |
Secondary | Anti-snake venom consumption | The total number of vials of the anti-venom administered including doses received prior to being brought to JIPMER. | up to 4 weeks | |
Secondary | New-onset organ failure | This includes acute kidney injury (AKI) defined as peak serum creatinine > 2 mg/dL, shock defined as systolic blood pressure < 90 mm Hg requiring use of vasopressors; bleeding from any site necessitating transfusion of blood/blood products; and capillary leak syndrome. | up to 4 weeks | |
Secondary | Death/need for surgical intervention | This would be a composite measure of death and/or need for surgical intervention. Death indicates in-hospital death due to any cause during the index hospitalisation. Surgical intervention would include need for any surgical intervention such as incision and drainage of abscess, wound debridement for necrosis or gangrene, fasciotomy for compartment syndrome, etc. | up to 4 weeks | |
Secondary | Drug-related adverse events | Any suspected or confirmed adverse drug reaction | up to 4 weeks |
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