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Pill power: oral antibiotic could replace IV for tough UTIs

NCT ID NCT06059846

Disease control Sponsor: Spero Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an oral antibiotic (tebipenem pivoxil hydrobromide) against a standard IV antibiotic in 1,690 hospitalized adults with complicated urinary tract infections or kidney infections. The goal was to see if the oral pill works as well as the IV treatment in curing the infection and clearing bacteria. Results could offer a more convenient, needle-free option for patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,690 people

The number who actually took part.

Started

Dec 2023

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 diarrhoea. 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.

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Conditions

The condition(s) this trial relates to.

acute pyelonephritis bacterial urinary tract infection urinary tract infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute pyelonephritis Urinary tract infection

Contacts and locations

Locations

  • Medical Facility

    Miami, Florida, 33176, United States

  • 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

  • Medical Facility

    Banja Luka, Bosnia and Herzegovina

  • Medical Facility

    Sarajevo, Bosnia and Herzegovina

  • Medical Facility

    Tuzla, Bosnia and Herzegovina

  • Medical Facility

    Barueri, Brazil

  • Medical Facility

    Campinas, Brazil

  • Medical Facility

    Curitiba, Brazil

  • Medical Facility

    Porto Alegre, Brazil

  • Medical Facility

    São José do Rio Preto, Brazil

  • Medical Facility

    Blagoevgrad, Bulgaria

  • Medical Facility

    Dobrich, Bulgaria

  • Medical Facility

    Gabrovo, Bulgaria

  • Medical Facility

    Pleven, Bulgaria

  • Medical Facility

    Plovdiv, Bulgaria

  • Medical Facility

    Sliven, Bulgaria

  • Medical Facility

    Varna, Bulgaria

  • Medical Facility

    Čakovec, Croatia

  • Medical Facility

    Slavonski Brod, Croatia

  • Medical Facility

    Split, Croatia

  • Medical Facility

    Zagreb, Croatia

  • Medical Facility

    Kohtla-Järve, Estonia

  • Medical Facility

    Pärnu, Estonia

  • Medical Facility

    Tallinn, Estonia

  • Medical Facility

    Tartu, 50406, Estonia

  • Medical Facility

    Võru, Estonia

  • Medical Facility

    Alexandroupoli, Greece

  • Medical Facility

    Athens, Greece

  • Medical Facility

    Ioannina, Greece

  • Medical Facility

    Pátrai, Greece

  • Medical Facility

    Thessaloniki, Greece

  • Medical Facility

    Budapest, Hungary

  • Medical Facility

    Eger, Hungary

  • Medical Facility

    Kistarcsa, Hungary

  • Medical Facility

    Nyíregyháza, Hungary

  • Medical Facility

    Belagavi, Karnataka, 590010, India

  • Medical Facility

    Bangalore, India

  • Medical Facility

    Jaipur, India

  • Medical Facility

    Lucknow, India

  • Medical Facility

    Varanasi, India

  • Medical Facility

    Daugavpils, Latvia

  • Medical Facility

    Liepāja, Latvia

  • Medical Facility

    Riga, Latvia

  • Medical Facility

    Valmiera, Latvia

  • Medical Facility

    Chisinau, Moldova

  • Medical Facility

    Krakow, Poland

  • Medical Facility

    Lodz, Poland

  • Medical Facility

    Warsaw, Poland

  • Medical Facility

    Łęczna, Poland

  • Medical Facility

    Brasov, Romania

  • Medical Facility

    Iași, Romania

  • Medical Facility

    Oradea, Romania

  • Medical Facility

    Timișoara, Romania

  • Medical Facility

    Bratislava, Slovakia

  • Medical Facility

    Galanta, Slovakia

  • Medical Facility

    Lučenec, Slovakia

  • Medical Facility

    Malacky, Slovakia

  • Medical Facility

    Poprad, Slovakia

  • Medical Facility

    Pretoria, South Africa

  • Medical Facility

    Tongaat, South Africa

  • Medical Facility

    Umhlanga, South Africa

  • Medical Facility

    Ankara, Turkey (Türkiye)

  • Medical Facility

    Diyarbakır, Turkey (Türkiye)

  • Medical Facility

    Istanbul, Turkey (Türkiye)

  • Medical Facility

    Izmir, Turkey (Türkiye)

  • Medical Facility

    Samsun, Turkey (Türkiye)

  • Medical facility

    Miami, Florida, 33144, United States

  • Medical facility

    Lom, Bulgaria

  • Medical facility

    Rousse, Bulgaria

  • Medical facility

    Shumen, Bulgaria

  • Medical facility

    Sofia, Bulgaria

  • Medical facility

    Tbilisi, Georgia

  • Medical facility

    Bucharest, Romania

  • Medical facility

    Craiova, Romania

  • Medical facility

    Belgrade, Serbia

  • Medical facility

    Kragujevac, Serbia

  • Medical facility

    Niš, Serbia

  • Medical facility

    Novi Sad, Serbia

  • Medical facility

    Benoni, South Africa

  • Medical facility

    Durban, South Africa

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