NCT03477422: PLEA

CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) Compared to Meropenem in Complicated Urinary Tract Infections (cUTIs) Caused by ESBL Producing Gram Negative Bacteria

Completed Phase 3 Last updated 29 August 2019

What this trial tests

Phase 3 trial testing CSE-1034 (Ceftriaxone + Sulbactam + EDTA) in Urinary Tract Infection Complicated in 230 participants. Completed in 8 May 2017.

Timeline

11 January 2014

Primary endpoint
8 May 2017

8 May 2017

Quick facts

Lead sponsor	Venus Remedies Limited
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	230
Start date	11 January 2014
Primary completion	8 May 2017
Estimated completion	8 May 2017
Sites	17 locations across India

Drugs / interventions tested

• CSE-1034 (Ceftriaxone + Sulbactam + EDTA) — full drug profile →
• Meropenem (Meropenem) — full drug profile →

Conditions studied

• Urinary Tract Infection Complicated — all drugs for Urinary Tract Infection Complicated →
• Acute Pyelonephritis — all drugs for Acute Pyelonephritis →

Sponsor

Venus Remedies Limited — full company profile →

Who can join

18 and older, any sex, with Urinary Tract Infection Complicated or Acute Pyelonephritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the effects of CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) compared to Meropenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis caused by β-lactamase producing gram-negative bacteria

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. CSE (Ceftriaxone+ Sulbactam+ Disodium EDTA) Versus Meropenem for the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis: PLEA, a Double-Blind, Randomized Noninferiority Trial.
   Mir MDA, Chaudhary S, Payasi A, Sood R, et al · · 2019 · cited 10× · PMID 31433059 · DOI 10.1093/ofid/ofz373
2. 1985. Atypical Symptoms and High Mortality Associated With Serogroup B Meningococcal Disease in Cartagena Colombia 2012–2016
   Coronell-Rodríguez W, Arteta-Acosta C. · · 2018
3. 1959. Ceftriaxone-Sulbactam-EDTA (CSE) vs. Meropenem (MR) in PLEA (a Phase 3, Randomized, Double-Blind Trial): Outcomes in Patients Infected With Ceftriaxone Non-Susceptible, Extended-Spectrum β-Lactamase and Multi-Drug-resistant Pathogens at Baseline
   Mir M, Chaudhary S, Mammen K, Sood R, et al · · 2018
4. 1958. Antiviral Effects, Pharmacokinetics (PK), and Safety of the Respiratory Syncytial Virus (RSV) Fusion Protein Inhibitor, JNJ-53718678 (JNJ-8678), in RSV-infected Infants With Bronchiolitis, in the Phase 1b Study 53718678RSV1005
   Martinon-Torres F, Rusch S, Huntjens D, Remmerie B, et al · · 2018
5. 1374. Integrated Safety Summary of Omadacycline: A Novel Aminomethylcycline Antibiotic
   Opal S, File T, Van Der Poll T, McGovern P, et al · · 2018
6. 1373. Activity of Ceftriaxone–Sulbactam–EDTA Against Multi-Drug-resistant A. baumannii, P. aeruginosa and Enterobacteriaceae Isolates (WHO Critical Priority Pathogens) Collected from Various Hospitals in India
   Girotra R, Pyasi A, Chaudhary M, Patil N, et al · · 2018
7. 1375. In vitro Activity of Cefiderocol and Comparator Agents against Gram-Negative Isolates from Cancer Patients
   Rolston K, Gerges B, Raad I, Aitken S, et al · · 2018
8. 1987. Validation of a MALDI-TOF MS-Based Direct-on-Target Microdroplet Growth Assay (DOT-MGA) for Rapid Detection of Extended-Spectrum β-Lactamase (ESBL) and AmpC in Clinical Enterobacteriaceae Isolates
   Correa-Martinez C, Idelevich E, Sparbier K, Kostrzewa M, et al · · 2018