10 completed. 7 Phase 1, 2 Phase 3, 1 Phase 2.
By phase and status
Follow tebipenem: new trials by email Literature Review of tebipenem trials Research Report on tebipenem
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix .
Trial Phase Status Sponsor Enrollment Start Updated
A Study to Characterize Single and Repeat Dose Pharmacokinetics of Tebipenem-Pivoxil-Hydrobromide (TBP-PI-HBr) and Its Major Metabolite (SPR1349) in Healthy Participants TBP-PI-HBr - Healthy Participants Phase 1 Completed 39 2024-11-20 2025-05-20 A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) TBP-PI-HBr, Imipenem-cilastatin, Dummy Infusion - Urinary Tract Infection, Acute Pyelonephritis Phase 3 Completed 1690 2023-12-21 2026-03-10 A Study to Compare Two Bioanalytical Assays for Tebipenem TBP-PI-HBr - Healthy Volunteers Phase 1 Completed 20 2023-05-04 2024-03-27 Tebipenem Trial in Children With Shigellosis Tebipenem Pivoxil, Azithromycin, Ceftriaxon - Shigellosis Phase 2 Completed 132 2022-08-18 2026-09-01 Study to Assess the Intrapulmonary Pharmacokinetics of SPR859 by Comparing the Plasma, Epithelial Lining Fluid (ELF), and Alveolar Macrophages (AM) Concentrations Following the Oral Administration of Five Doses of SPR994 in Healthy, Nonsmoking Volunteers TBPM-PI-HBr - Healthy Volunteers Phase 1 Completed 30 2020-12-07 2021-03-16 Study to Examine the Effect of Antacid and Omeprazole on the Single-Dose Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects Tebipenem pivoxil hydrobromide (TBPM-PI-HBr), 20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL), Omeprazole - Healthy Volunteers Phase 1 Completed 20 2020-07-01 2020-09-04 A Single-Dose, Randomized, Placebo- and Active-Control, Four-Way, Cross-Over Study for the Evaluation of the Effect of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) on the QT/QTc Intervals in Adult Healthy Subjects Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) + Placebo, Moxifloxacin 400mg, Placebo for Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) - TQT Study Phase 1 Completed 24 2020-01-19 2020-03-13 Phase 1 Study of PK and Safety of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Subjects With Various Degrees Of Renal Function Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Renal Impairment Phase 1 Completed 39 2019-12-06 2020-11-27 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) TBPM-PI-HBr, Ertapenem, Dummy Infusion - Complicated Urinary Tract Infection, Acute Pyelonephritis Phase 3 Completed 1372 2019-06-03 2022-07-25 Phase 1 Study of Safety, Tolerability and Pharmacokinetics of SPR994 SPR994, Placebo Oral Tablet, Orapenem® - Healthy Volunteers Phase 1 Completed 124 2017-10-20 2018-08-28
Conditions studied Dysentery, Bacillary (1) · Kidney Diseases (1) · Renal Insufficiency (1) · Urinary Tract Infections (1)
Sponsors Spero Therapeutics (9) · International Centre for Diarrhoeal Disease Research, Bangladesh (1)
Countries United States (8) · Bulgaria (2) · Estonia (2) · Georgia (2) · Hungary (2) · Latvia (2) · Moldova (2) · Poland (2) · Romania (2) · Serbia (2) · Slovakia (2) · South Africa (2) · Argentina (1) · Australia (1) · Bangladesh (1)
Top investigators David Melnick, M.D. (2) · Charlotte Lemech, FRACP, MD (1) · David Baratz, MD (1) · David Hong, MD (1) · David Melnick, MD (1) · Sharika Nuzhat, MBBS, DCH (1)
Results publications PMID 31262768 , PMID 35388666 , PMID 35420493 , PMID 35762796 , PMID 40000088
NIH funding 2018 (1) , 2023 (1)