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Comparing oral and intravenous antibiotics for complicated urinary tract infections

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)

Phase 3 Interventional Spero Therapeutics · NCT06059846

This study is testing if an oral antibiotic can work as well as an intravenous one for treating complicated urinary tract infections in hospitalized adults.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment2648 (estimated)
Ages18 Years and up
SexAll
SponsorSpero Therapeutics Industry-sponsored
Locations86 sites (Miami, Florida and 85 other locations)
Trial IDNCT06059846 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) compared to intravenous Imipenem-cilastatin in treating hospitalized adults with complicated urinary tract infections (cUTI) or acute pyelonephritis (AP). Participants will be assessed for clinical cure and microbiological eradication at the Test-of-Cure visit. The study aims to determine if the oral medication can provide similar or better outcomes than the intravenous option, potentially improving patient convenience and treatment adherence.

Who should consider this trial

Good fit: Ideal candidates are hospitalized adults aged 18 and older diagnosed with complicated urinary tract infections or acute pyelonephritis.

Not a fit: Patients with conditions that may interfere with the assessment of efficacy or those requiring interventions for gross hematuria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more convenient oral treatment option for patients with complicated urinary tract infections.

How similar studies have performed: Other studies have shown promising results with oral antibiotics for similar infections, but this specific approach is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Have a diagnosis of cUTI or AP.
2. 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:

   1. at least 10 white blood cells (WBCs) per high power field (HPF) in urine sediment
   2. at least 10 WBCs per millimeters cubed (mm\^3) in unspun urine
   3. 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.
3. 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.

Exclusion Criteria:

1. Presence of any known or suspected disease or condition that may confound the assessment of efficacy.
2. Gross hematuria requiring intervention other than administration of study drug or removal/placement of urinary tract instrumentation.
3. Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period.
4. Creatinine clearance (CrCl) of ≤30 milliliters per minute (mL/min), as estimated by the Cockcroft-Gault formula.
5. Anticipated concomitant use of non-study antimicrobial drug therapy between randomization and the LFU visit that would potentially effect outcome evaluations of cUTI/AP.
6. Receipt of a potentially effective antimicrobial within 72 hours prior to study randomization.
7. 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).
8. Pregnant or lactating women.
9. History of epilepsy or known seizure disorder (excluding a history of childhood febrile seizures).
10. History of proven or suspected Clostridioides difficile associated diarrhea.
11. History of human immunodeficiency virus (HIV) infection.
12. QT interval corrected using Fridericia's formula (QTcF) \>480 milliseconds (msec) based on screening ECG.
13. History of known genetic metabolism anomaly associated with carnitine deficiency.
14. Requirement for concomitant use of valproic acid, divalproex sodium, or probenecid between randomization and EOT.

Note: Other inclusion and exclusion criteria as per protocol may apply.

Where this trial is running

Miami, Florida and 85 other locations

+36 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Urinary Tract InfectionAcute Pyelonephritis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.