Trial intelligence / Profile preview

Single vs Multiple-dose Prophylaxis in POEM for Achalasia

NCT03404739Phase 3

Key facts

Status: Unknown
Start: Oct 2017
Primary completion: Dec 2018
Countries: 1
Sponsor: Zhongshan Hospital, Fudan University
Modality: Reversible Covalent Inhibitors

Drugs: ceftazidime
Conditions: bacterial infection

Overview

Phase 3, randomised, triple-blind trial of ceftazidime in bacterial infection (2 arms), sponsored by Zhongshan Hospital, Fudan University. Primary endpoint: Infectious complications associated with POEM at 4 weeks. Status: unknown.

Design

2 arms

Study design: RandomizedTriple-blind

Single-dose group
Ceftazidime 2g at start of POEM + Saline placebo post-op
Multiple-dose group
Ceftazidime 2g at start of POEM + Ceftazidime post-op

Who it enrols

Patients with esophageal achalasia undergoing POEM, excluding those with ASA score >=3, recent antibiotic use, active infection, pregnancy, immunodeficiency, or steroid therapy.

Endpoints

Primary

Infectious complications associated with POEM4 weeks

Secondary

Pathogens for causing infection4 weeks
Adverse effects of antibiotics4 weeks
Clavien-Dindo classification of surgical complications4 weeks
Length of hospital stayadmission to discharge
Efficacy of POEM4 weeks

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