# Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

> **NCT03788967** · PHASE3 · COMPLETED · sponsor: **Spero Therapeutics** · enrollment: 1372 (actual)

## Conditions studied

- Complicated Urinary Tract Infection
- Acute Pyelonephritis

## Interventions

- **DRUG:** TBPM-PI-HBr
- **DRUG:** Ertapenem
- **DRUG:** Dummy Infusion
- **DRUG:** Dummy tablets

## Key facts

- **NCT ID:** NCT03788967
- **Lead sponsor:** Spero Therapeutics
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2019-06-03
- **Primary completion:** 2020-05-20
- **Final completion:** 2020-05-27
- **Target enrollment:** 1372 (ACTUAL)
- **Last updated:** 2022-07-25


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03788967

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03788967, "Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT03788967. Licensed CC0.

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