Uncomplicated Urinary Tract InfectionsPhase 2NCT07871968
A Study to Investigate Pivmecillinam Versus Nitrofurantoin in Female Adolescents 12 to Less Than 18 Years of Age With Uncomplicated Urinary Tract Infection
A Phase 2 study testing Pivya (Pivmecillinam 185 mg) and Nitrofurantoin 100 mg (nitrofurantoin monohydrate/macrocrystalline capsule) in people with Uncomplicated Urinary Tract Infections, run by Alembic Therapeutics at 1 site in United States.
Trial summary
Multicenter, Randomized, Open-label, Active-controlled Study with Blinded Assessor to Evaluate the Safety and Tolerability of Pivmecillinam Hydrochloride versus Nitrofurantoin for the Treatment of Female Pediatric Subjects, 12 Years to Less Than 18 Years of Age, with Uncomplicated Urinary Tract Infections Read more about this study
- Who is it for?
- Ages 12 to 17 years, women only
- Conditions the study is for
- Uncomplicated Urinary Tract Infections
- What is being tested?
- Pivya (Pivmecillinam 185 mg) and Nitrofurantoin 100 mg (nitrofurantoin monohydrate/macrocrystalline capsule)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2026to 28 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Female adolescents 12 years to less than 18 years of age at the time of consent and a body weight ≥ 40 kg (≥ 88 lbs).
- Written informed consent from parent(s) or legally acceptable representative(s), and informed assent from participant (according to the local regulations) before initiation of any trial-related procedures.
- Able to supply a urine specimen from clean-catch midstream urine sample.
- Have 2 or more of the following clinical signs and symptoms of acute cystitis with onset ≤ 96 hours prior to trial entry: dysuria, urinary frequency, urinary urgency, or suprapubic pain (lower abdominal pain).
- A urine specimen* that is positive for nitrite, pyuria, or the presence of 3 plus (+)/large leukocyte esterase. Evidence of pyuria is to be confirmed by either a urine specimen that is positive for leukocyte esterase via urine dipstick or urinalysis, or a urine specimen with either > 10 white blood cells (WBCs) per microliter from an unspun urine or > 5 WBCs per high power field from a centrifuged specimen.
- Note: Sample obtained from clean-catch midstream urine sample.
Show all 11Show fewer
- Participants of childbearing potential (who have reached menarche) will be advised to avoid conception and not to attempt pregnancy from the time of screening until 7 days after the end of trial treatment and will be provided guidelines regarding the continuation of abstinence, initiation of abstinence, or about allowed contraception. Participants of childbearing potential must meet the following criteria:
- Report use of at least 1 of the acceptable methods of contraception, including an intrauterine device (with copper banded coil), levonorgestrel intrauterine system, or regular medroxyprogesterone injections (Depo Provera®); or
- Agree to initiate sexual abstinence from the time of screening until 7 days after the end of trial treatment.
- Participants of childbearing potential (who have reached menarche) must have a negative pregnancy test result from a validated assay* with a sensitivity of ≤ 25 IU/L human chorionic gonadotropin (hCG).
- Note: Local urine testing will be standard for the protocol unless serum testing is required by local regulation or IRB
Who cannot join
- Participants are excluded from the trial if any of the following criteria apply:
- Signs or symptoms of systemic illness such as fever (temperature ≥ 38.0 °C [100.4 °F]), shaking chills, or other clinical manifestations suggestive of cUTI such as acute flank pain or costovertebral angle tenderness.
- Presence of risk factors for cUTI, including urinary tract instrumentation, nephrostomy, ureter stent or other foreign material (including catheter), nephrolithiasis, current known functional or anatomical abnormality of the urogenital tract (including kidneys), complete or partial obstructive uropathy, urinary retention, or known underlying renal disease with blood urea nitrogen (BUN) > 20 mg/dL, or serum creatinine > 1.4 mg/dL.
- Multi-recurrent UTI (defined as 3 or more previous UTIs within a 6-month period).
- Receipt of systemic antibacterials within the 7 days prior to first dose of trial drug. Note: Topical antimicrobial for skin or otic or ophthalmic infection is allowed.
- Receipt of immunotherapy treatment through an autovaccine for UTI recurrence prevention within 72 hours prior to the first dose of trial drug and for the duration of the trial.
Show all 24Show fewer
- Treatment with valproic acid, valproate, or other medication liberating pivalic acid (such as corticosteroid pivalates or hormonal pivalate esters due to increased risk of carnitine depletion) within 72 hours prior to the first dose of trial drug and for the duration of the trial.
- Known hypersensitivity to beta-lactam antibiotics (e.g., cephalosporins, penicillins, carbapenems, and monobactams), or to nitrofurantoin, as well as known allergy/hypersensitivity to any component of the trial drug, including excipients.
- Genetic metabolism anomalies known to lead to severe carnitine deficiency, such as carnitine transporter defect, methylmalonic aciduria or propionic acidemia.
- Known underlying kidney disease.
- Pre-existing polyneuropathy and/or optic neuritis.
- Known or suspected renal impairment.
- Known or suspected severe hepatic impairment including clinical signs of cirrhosis or end stage hepatic disease (e.g., ascites, hepatic encephalopathy), excluding isolated hyperbilirubinemia consistent with suspected or known Gilbert's syndrome.
- Medical history of porphyria.
- Known glucose-6 phosphate dehydrogenase deficiency.
- Previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin.
- Infection at another site, excluding skin, mucous, or ocular infections that can be treated with topical antimicrobials.
- Any potentially immune compromising condition (e.g. uncontrolled diabetes, renal transplant recipients, patients with clinically significant persistent granulocytopenia [absolute neutrophil count < 1000/μL], and patients receiving systemic immunosuppressive therapy, including systemic corticosteroid therapy [> 40 mg/day prednisolone or equivalent for > 1 week, ≥ 20 mg/day prednisolone or equivalent for > 2 weeks, or prednisolone or equivalent ≥ 10 mg/day for > 6 weeks]), or known CD4 count of < 200 cells/mm3.
- Poorly controlled asthma or chronic obstructive pulmonary disease at screening and, in the opinion of the Investigator, not stable on current therapy.
- Vomiting or not able to tolerate oral medication.
- Pregnancy or lactation or considering becoming pregnant.
- Unable or unwilling, in the judgment of the Investigator, to comply with the protocol or complete the clinical trial.
- Receipt of any investigational medication or investigational device during the 30 days prior to enrollment.
- Any acute or chronic illness/condition or evidence of an unstable clinical condition that, in the opinion of the Investigator, would place the participant at increased risk if participating in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Alembic Clinical Trial Site
Dearborn Heights, Michigan, 48127
Recruiting Coordinator, (908) 569-7456, clinicaltrials@alembictx.com
About this study
Official title: Multicenter, Randomized, Open-label, Active-controlled Study With a Blinded Assessor to Evaluate the Safety and Tolerability of Pivmecillinam Hydrochloride Versus Nitrofurantoin for the Treatment of Female Pediatric Subjects, 12 Years to Less Than 18 Years of Age, With Uncomplicated Urinary Tract Infections
Multicenter, Randomized, Open-label, Active-controlled Study with Blinded Assessor to Evaluate the Safety and Tolerability of Pivmecillinam Hydrochloride versus Nitrofurantoin for the Treatment of Female Pediatric Subjects, 12 Years to Less Than 18 Years of Age, with Uncomplicated Urinary Tract Infections
Read the detailed description
This is a Phase 2 multicenter, randomized, open-label, active-controlled trial with a blinded assessor of pivmecillinam versus nitrofurantoin in female pediatric participants 12 years to less than 18 years of age with uUTI.
Approximately 100 female pediatric participants will be randomized 2:1 to pivmecillinam or nitrofurantoin. Randomized participants will take pivmecillinam (185 mg, three times daily [TID] orally) or nitrofurantoin (100 mg, twice daily [BID] orally) for 5 days.
The screening visit can occur up to 24 hours prior to the first dose of trial drug. Therefore, the screening procedures and first day of trial drug dosing could occur on the same day. Day 1 starts with the first trial drug dose and continues to 23:59 on the same calendar day. On Day 1, randomized participants will receive their first dose of trial drug at the on-site visit. Participants will be given training on proper trial drug intake and they will be given a supply of trial drug for the remainder of at-home administration. Assessments will be conducted during the on-site visits.
Trial drug treatment duration will be for 5 days, including 2 site visits ending with the EOT visit on Day 6 (+2 days). Symptoms of uUTI as well as clinical and microbiological responses will be assessed at the EOT visit and the TOC visit on Day 12 (±2 days).
Following the TOC visit, participants will have a long-term follow-up (LFU) phone call approximately 30 days after the initiation of trial drug treatment. For participants who have clinical cure documented at the TOC visit, an assessment for the maintenance of clinical response will occur at the LFU phone call. Safety data will be captured from the time of informed consent and assent through LFU phone call.
- Conditions
- Uncomplicated Urinary Tract Infections
- Being tested
- Pivya (Pivmecillinam 185 mg), Nitrofurantoin 100 mg (nitrofurantoin monohydrate/macrocrystalline capsule)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pivya (Pivmecillinam 185 mg)Drug
Pivmecillinam 185 mg TID for 5 days, taken orally with or without food
Nitrofurantoin 100 mg (nitrofurantoin monohydrate/macrocrystalline capsule)Drug
100 mg (nitrofurantoin monohydrate/macrocrystalline capsule) BID for 5 days, taken orally with food
| Study group | Role | What they receive |
|---|---|---|
| Pivya | Experimental | 185 mg (pivmecillinam HCl 200 mg, henceforth referred to as pivmecillinam 185 mg) TID for 5 days, taken orally with or without food Receives: Drug: Pivya (Pivmecillinam 185 mg) |
| Nitrofurantoin | Active comparator | 100 mg (nitrofurantoin monohydrate/macrocrystalline capsule) BID for 5 days, taken orally with food Receives: Drug: Nitrofurantoin 100 mg (nitrofurantoin monohydrate/macrocrystalline capsule) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Adverse Events
Safety will be evaluated by incidences of TEAEs, clinical laboratory evaluations, ECGs, vital signs, and physical examination findings for each treatment group
Measured: From enrollment to the end of treatment at 5 days
Secondary outcomes (3)
Overall response at EOT
Overall response at EOT is determined based on the combined assessment of clinical and microbiological responses. The number and percentage of participants in each overall response category at EOT defined as a success, failure, and indeterminate will be tabulated by treatment arm in the ITT, micro-ITT and CE-EOT analysis sets. Two-sided 95% confidence intervals (CIs) for the difference in overall success rates (pivmecillinam minus comparator) will be calculated using the normal approximation to the binomial with a continuity correction.
Measured: From enrollment to the end of treatment at 5 days
Overall response at TOC
Overall response at TOC is determined based on the combined assessment of clinical and microbiological responses. Overall response at TOC will be analyzed similarly to overall response at EOT in the ITT, micro ITT and CE-TOC analysis sets.
Measured: From enrollment to the end of treatment at 5 days
Clinical and Microbiological Responses
The number and percentage of participants in each treatment arm with a response of clinical success, clinical failure and indeterminate at EOT will be presented in the ITT, micro-ITT and CE-EOT analysis sets. Two-sided 95% CIs for the difference in clinical success rates (pivmecillinam minus comparator) will be calculated using the normal approximation to the binomial with a continuity correction. Clinical response at TOC will be analyzed similarly to clinical response at EOT in the ITT, microITT and CE-TOC analysis sets. The number and percentage of participants in each treatment arm with a response of microbiologic success, microbiologic failure and indeterminate at EOT will be presented in the micro-ITT and ME-EOT analysis sets. Two-sided 95% CIs for the difference in microbiologic success rates (pivmecillinam minus comparator) will be calculated using the normal approximation to the binomial with a continuity correction. Microbiological response at TOC will be analyzed s
Measured: From enrollment to the end of treatment at 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start24 Oct 2026 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncomplicated Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alembic Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FOTREA CRO
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871968
- Sponsor's protocol ID
- 118650
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The Sponsor has not yet determined whether individual participant data (IPD) from this study will be made available to other researchers. The decision regarding IPD sharing will be made following study completion and will take into consideration applicable regulatory requirements, participant privacy and confidentiality, and Sponsor policies regarding data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Open-label, Active-controlled Study With a Blinded Assessor to Evaluate the Safety and Tolerability of Pivmecillinam Hydrochloride Versus Nitrofurantoin for the Treatment of Female Pediatric Subjects, 12 Years to Less Than 18 Years of Age, With Uncomplicated Urinary Tract Infections
- ClinicalTrials.gov ID
- NCT07871968
- Acronym / sponsor ID
- 118650
- Conditions
- Uncomplicated Urinary Tract Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Alembic TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- FOTREA CRO
- Study start
- 24 Oct 2026 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter, Randomized, Open-label, Active-controlled Study with Blinded Assessor to Evaluate the Safety and Tolerability of Pivmecillinam Hydrochloride versus Nitrofurantoin for the Treatment of Female Pediatric Subjects, 12 Years to Less Than 18 Years of Age, with Uncomplicated Urinary Tract Infections
Detailed description
This is a Phase 2 multicenter, randomized, open-label, active-controlled trial with a blinded assessor of pivmecillinam versus nitrofurantoin in female pediatric participants 12 years to less than 18 years of age with uUTI.
Approximately 100 female pediatric participants will be randomized 2:1 to pivmecillinam or nitrofurantoin. Randomized participants will take pivmecillinam (185 mg, three times daily [TID] orally) or nitrofurantoin (100 mg, twice daily [BID] orally) for 5 days.
The screening visit can occur up to 24 hours prior to the first dose of trial drug. Therefore, the screening procedures and first day of trial drug dosing could occur on the same day. Day 1 starts with the first trial drug dose and continues to 23:59 on the same calendar day. On Day 1, randomized participants will receive their first dose of trial drug at the on-site visit. Participants will be given training on proper trial drug intake and they will be given a supply of trial drug for the remainder of at-home administration. Assessments will be conducted during the on-site visits.
Trial drug treatment duration will be for 5 days, including 2 site visits ending with the EOT visit on Day 6 (+2 days). Symptoms of uUTI as well as clinical and microbiological responses will be assessed at the EOT visit and the TOC visit on Day 12 (±2 days).
Following the TOC visit, participants will have a long-term follow-up (LFU) phone call approximately 30 days after the initiation of trial drug treatment. For participants who have clinical cure documented at the TOC visit, an assessment for the maintenance of clinical response will occur at the LFU phone call. Safety data will be captured from the time of informed consent and assent through LFU phone call.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pivya | Experimental | Drug: Pivya (Pivmecillinam 185 mg)185 mg (pivmecillinam HCl 200 mg, henceforth referred to as pivmecillinam 185 mg) TID for 5 days, taken orally with or without food |
| Nitrofurantoin | Active comparator | Drug: Nitrofurantoin 100 mg (nitrofurantoin monohydrate/macrocrystalline capsule)100 mg (nitrofurantoin monohydrate/macrocrystalline capsule) BID for 5 days, taken orally with food |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Female adolescents 12 years to less than 18 years of age at the time of consent and a body weight ≥ 40 kg (≥ 88 lbs).
- Written informed consent from parent(s) or legally acceptable representative(s), and informed assent from participant (according to the local regulations) before initiation of any trial-related procedures.
- Able to supply a urine specimen from clean-catch midstream urine sample.
- Have 2 or more of the following clinical signs and symptoms of acute cystitis with onset ≤ 96 hours prior to trial entry: dysuria, urinary frequency, urinary urgency, or suprapubic pain (lower abdominal pain).
- A urine specimen* that is positive for nitrite, pyuria, or the presence of 3 plus (+)/large leukocyte esterase. Evidence of pyuria is to be confirmed by either a urine specimen that is positive for leukocyte esterase via urine dipstick or urinalysis, or a urine specimen with either > 10 white blood cells (WBCs) per microliter from an unspun urine or > 5 WBCs per high power field from a centrifuged specimen.
Key exclusion criteria (24 listed)
- Signs or symptoms of systemic illness such as fever (temperature ≥ 38.0 °C [100.4 °F]), shaking chills, or other clinical manifestations suggestive of cUTI such as acute flank pain or costovertebral angle tenderness.
- Presence of risk factors for cUTI, including urinary tract instrumentation, nephrostomy, ureter stent or other foreign material (including catheter), nephrolithiasis, current known functional or anatomical abnormality of the urogenital tract (including kidneys), complete or partial obstructive uropathy, urinary retention, or known underlying renal disease with blood urea nitrogen (BUN) > 20 mg/dL, or serum creatinine > 1.4 mg/dL.
- Multi-recurrent UTI (defined as 3 or more previous UTIs within a 6-month period).
- Receipt of systemic antibacterials within the 7 days prior to first dose of trial drug. Note: Topical antimicrobial for skin or otic or ophthalmic infection is allowed.
- Receipt of immunotherapy treatment through an autovaccine for UTI recurrence prevention within 72 hours prior to the first dose of trial drug and for the duration of the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pivya (Pivmecillinam 185 mg)Pivmecillinam 185 mg TID for 5 days, taken orally with or without food | Drug | Pivya |
| Nitrofurantoin 100 mg (nitrofurantoin monohydrate/macrocrystalline capsule)100 mg (nitrofurantoin monohydrate/macrocrystalline capsule) BID for 5 days, taken orally with food | Drug | Nitrofurantoin |
Primary outcome
Incidence of Treatment Emergent Adverse Events
Time frame: From enrollment to the end of treatment at 5 days
Safety will be evaluated by incidences of TEAEs, clinical laboratory evaluations, ECGs, vital signs, and physical examination findings for each treatment group
3 secondary outcomes
Overall response at EOT
Time frame: From enrollment to the end of treatment at 5 days
Overall response at TOC
Time frame: From enrollment to the end of treatment at 5 days
Clinical and Microbiological Responses
Time frame: From enrollment to the end of treatment at 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided. The Sponsor has not yet determined whether individual participant data (IPD) from this study will be made available to other researchers. The decision regarding IPD sharing will be made following study completion and will take into consideration applicable regulatory requirements, participant privacy and confidentiality, and Sponsor policies regarding data sharing.
Related trials for Uncomplicated Urinary Tract Infections
RecruitingPhase 3
Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated rUTIs in Women
Recurrent Urinary Tract Infections in Women
RecruitingPhase 2
A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)
Urinary Tract Infections
RecruitingObservational study
Single Dose Amikacin for Uncomplicated Cystitis in the ED: A Feasibility Study
Urinary Tract Infections
Not yet recruiting
Urine Alkalinization for UTI in Women: RCT
UTI - Urinary Tract Infection
RecruitingObservational study
Rapid Point-of-care Bacteriuria and Microbial Susceptibility for Women With Suspected Uncomplicated Urinary Tract Infections: Diagnostic Accuracy in General Practice.
Urinary Tract Infection (Diagnosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pivya (Pivmecillinam 185 mg) and Nitrofurantoin 100 mg (nitrofurantoin monohydrate/macrocrystalline capsule) in people with Uncomplicated Urinary Tract Infections, run by Alembic Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Bardin, PharmD, BCPS ((908) 569-7456, clinicaltrials@alembictx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Emergent Adverse Events (time frame: From enrollment to the end of treatment at 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.