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Antibiotic shot under skin could replace IV drip for serious infections
NCT ID NCT07481539
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether a powerful antibiotic called piperacillin/tazobactam can be given as a continuous shot under the skin instead of through an IV line. About 240 adults with serious bacterial infections will be randomly assigned to receive the drug either subcutaneously or intravenously. The main goal is to see if the subcutaneous method provides similar drug levels in the blood and is safe. If it works, this could make treatment more convenient and less invasive.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Piperacillin/tazobactam (antibiotic combination)
- What this could lead to
- If successful, this could offer a simpler, less invasive way to deliver a powerful antibiotic, potentially reducing hospital stays and discomfort for patients.
- What could go wrong
- This is a Phase 2 trial with only 240 participants, so results are preliminary. The subcutaneous route may not achieve the same drug levels as IV, and there could be injection-site reactions or other safety issues.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Free, written and informed consent signed by the participant; * At least 18 years old on the day of inclusion; * Male and female participants; * Clinical indication for treatment with piperacillin/tazobactam 18g/die in continuous infusion, including severe pneumonia, neutropenic fever suspected to be caused by bacterial infection or other severe bacterial infections for which, based on investigator's judgment, this dosage regimen is appropriate; * Evidence of postmenopausal status, defined as no menses for at least 12 consecutive months without an alternative medical cause and, if clinically indicated, confirmed by serum FSH levels in the postmenopausal range; or Negative serum pregnancy test at the screening visit (sensitivity ≥25 mIU/mL) and negative urine β-HCG test at the End-of-Treatment (D8) for females of childbearing potential who are sexually active with a non-sterilized male partner. Women of childbearing potential (WOCBP) are defined as all women who are not surgically sterile (bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) and who are not postmenopausal; \- Admitted to one of the wards authorized for the enrollment. Exclusion Criteria: * Known hypersensitivity to penicillins, cephalosporins, other β-lactamase inhibitors, or any component of the formulation; * Pregnant or breastfeeding women, and women intending to become pregnant during the study or within the End-of-Treatment visit; * Women of childbearing potential (WOCBP) unwilling or unable to use at least one highly effective method of contraception, as defined in Section 7.4, throughout study participation and for at least at the End-of-Treatment visit; * No indication for treatment with TZP; * Known resistance to TZP; * Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications; * Participation in another clinical trial with administration of an investigational medicinal product (IMP) within 30 days prior to screening or within 5 half-lives of that IMP, whichever is longer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Azienda Sanitaria Universitaria Friuli Centrale
RECRUITINGUdine, Italia/UD, 33100, Italy