A Phase 3, Randomized, Double-blind, Double-dummy, Multicenter, Multinational Study to Assess the Efficacy and Safety of Orally Administered Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenously Administered Imipenem-cilastatin in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

CompletadoFase 3ClinicalTrials.gov

ID: NCT06059846Tipo: INTERVENTIONALInicio: 21 de dic de 2023Fin estimado: 6 de feb de 2025

Traducción no disponible, mostrando original

Resumen

The primary purpose of this study is to assess the efficacy of oral TBP-PI-HBr as compared with intravenous (IV) imipenem-cilastatin with respect to the overall response (combined clinical cure plus microbiological eradication) at the Test-of-Cure (TOC) visit in hospitalized adult participants (greater than or equal to (≥)18 years of age) with cUTI or AP.

Descripción detallada

The study included a pre-planned interim analysis with stopping criteria for efficacy and futility that was performed by an independent data monitoring committee (IDMC). For full details please refer to the protocol and statistical analysis plan.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have a diagnosis of cUTI or AP.
Have an adequate urine specimen for evaluation and culture obtained within 24 hours prior to randomization with evidence of pyuria that includes at least one of the following:
at least 10 white blood cells (WBCs) per high power field (HPF) in urine sediment
at least 10 WBCs per millimeters cubed (mm\^3) in unspun urine
positive leukocyte esterase (LE) on urinalysis Note: Participants may be randomized and administered study drug prior to knowledge of urine culture results, but pyuria must be documented.
Expectation, in the judgment of the Investigator, that the participant will survive with effective antimicrobial therapy and appropriate supportive care for the anticipated duration of the study.

Criterios de exclusión

Presence of any known or suspected disease or condition that may confound the assessment of efficacy.
Gross hematuria requiring intervention other than administration of study drug or removal/placement of urinary tract instrumentation.
Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period.
Creatinine clearance (CrCl) of ≤30 milliliters per minute (mL/min), as estimated by the Cockcroft-Gault formula.
Anticipated concomitant use of non-study antimicrobial drug therapy between randomization and the LFU visit that would potentially effect outcome evaluations of cUTI/AP.
Receipt of a potentially effective antimicrobial within 72 hours prior to study randomization.
Severe hepatic impairment at Screening, as evidenced by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5×upper limit of normal (ULN) or total bilirubin \>3×ULN, or clinical signs of cirrhosis or end-stage hepatic disease (e.g., ascites, hepatic encephalopathy).
Pregnant or lactating women.
History of epilepsy or known seizure disorder (excluding a history of childhood febrile seizures).
History of proven or suspected Clostridioides difficile associated diarrhoea.
History of human immunodeficiency virus (HIV) infection.
QT interval corrected using Fridericia's formula (QTcF) \>480 milliseconds (msec) based on screening ECG.
History of known genetic metabolism anomaly associated with carnitine deficiency.
Requirement for concomitant use of valproic acid, divalproex sodium, or probenecid between randomization and EOT.

Intervenciones

drug

TBP-PI-HBr

TBP-PI-HBr film-coated immediate-release tablets.

drug

Imipenem-cilastatin

Sterile powder for reconstitution administered as IV.

drug

Dummy Infusion

0.9% sodium chloride administered as IV infusion.

drug

Dummy Tablets

TBP-PI-HBr matching dummy tablets.

Ubicaciones

Medical Facility

Buenos Aires, Argentina

Medical Facility

Córdoba, Argentina

Medical Facility

La Plata, Argentina

Medical Facility

Mendoza, Argentina

Medical Facility

San Miguel de Tucumán, Argentina

Medical Facility

Villa Regina, Argentina

Patrocinadores

PrincipalSpero Therapeutics

ColaboradorGlaxoSmithKline

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Phase 3, Randomized, Double-blind, Double-dummy, Multic... | EligiMed