A Phase I/Phase II randomized controlled trial (RCT) of a new antivenom, compared to the currently used CSL taipan antivenom, for the treatment of the effects of Papuan taipan bite

Phase 1

Recruiting

• Conditions: Papuan taipan (Oxyuranus scutellatus) envenoming; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12612001062819
• Lead Sponsor: niversity of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 388

Inclusion Criteria

(i). Only patients who present to the Emergency Department within four (4) hours post-bite;
(ii). Who meet predetermined minimal criteria for the diagnosis of taipan envenoming;
(iii). Give informed consent; and,
(iv). Do not have any of the predetermined exclusion criteria, will be enrolled.
(v). Patients who present more than four (4) hours post-bite, or who have any other exclusion
criteria, will be treated according to the current national protocol.

Exclusion Criteria

(i). All patients who present to hospital more than four (4) hours post-bite;
(ii). Any patients with clinical evidence of intracranial haemorrhage;
(iii). Any patient with progressive oropharyngeal paralysis with partial or complete loss of airway
patency, including any patient requiring endotracheal intubation;
(iv). Any patient with significant known co-morbidities (such as active TB, AIDS, diabetes
requiring medication or ischaemic heart disease);
(v). Any patient who has already received treatment with antivenom at another health facility.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevention of airway obstruction or respiratory failure (the two most lethal effects of taipan venom) post-antivenom.[24 hours post-treatment];Restoration of blood coagulability, as determined by a negative 20 minute whole blood clotting test validated by laboratory findings of normal range PT, APTT and fibrinogen measured on a Diagnostica Stago STA Compact Haemostasis system.[48 hours post-treatment]

Secondary Outcome Measures

Name	Time	Method
ength of hospital stay[Measured from time of admission to time of discharge]