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NCT03788967 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by Spero Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,372
- Enrollment target
NCT03788967 is a Phase 3 study that has completed, run by Spero Therapeutics. The registered enrollment target is 1,372 participants.
The verdict
NCT03788967, a Phase 3 study, has completed, sponsored by Spero Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,372 participants
- Enrollment target
Study Summary
The key purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) compared to intravenous (IV) ertapenem, in participants with complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP).
Interventions
- DRUG Ertapenem
- DRUG TBPM-PI-HBr
- DRUG Dummy Infusion
- DRUG Dummy tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,372 participants |
| Start Date | 2019-06-03 |
| Est. Completion | 2020-05-27 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03788967
The ClinicalTrials.gov registry entry for NCT03788967 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,372 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spero Therapeutics, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Ertapenem is the first listed.
NCT03788967 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03788967 about?
NCT03788967 is a clinical study titled "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)". The key purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) compared to intravenous (IV) ertapenem, in participants with complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP).
What is the current status of trial NCT03788967?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,372 participants. The study started on 2019-06-03. Estimated completion is 2020-05-27.
What interventions are being tested in trial NCT03788967?
The interventions under investigation include: Ertapenem (DRUG), TBPM-PI-HBr (DRUG), Dummy Infusion (DRUG), Dummy tablets (DRUG).
Who is sponsoring clinical trial NCT03788967?
This trial is sponsored by Spero Therapeutics, which has 14 total clinical trials registered on ClinicalTrials.gov.
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