PyelonephritisTEMOKID-POPNCT07070102
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
An observational study of Pyelonephritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Temocillin, a 6-alpha-methoxypenicillin derivative of ticarcillin, is a narrow-spectrum antibiotic, primarily restricted to Enterobacterales. Therefore, its prescription for the treatment of febrile urinary tract infections requiring hospitalization in pediatrics appears interesting. Read more about this study
- Who is it for?
- Ages 1 day to 15 years
- Conditions the study is for
- Pyelonephritis
- What is being tested?
- blood samples
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2025to 1 Sep 2027
- Phase
- Observational
- 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 1 day to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Patient aged 0 to 15 years (inclusive) presenting with a febrile urinary tract infection with BGN requiring hospitalization in the departments of the Robert-Debré University Hospital for a duration of at least 48 hours
Who may be able to join
- Patient aged 0 to 15 years
- Presenting with a febrile urinary tract infection due to GNR (a febrile urinary tract infection is defined as a urine culture showing significant leukocyturia (≥104) and direct examination showing GNR, in a patient with fever)
- Requiring hospitalization in the general pediatrics, emergency (short-stay hospitalization unit), nephrology, or intensive care units of the Robert-Debré University Hospital for a presumed period of at least 48 hours.
- Non-opposition of the legal representatives obtained by one of the investigator
Who cannot join
- Presence of sepsis (Phoenix score ≥ 2)
- Gram-positive cocci (GPC) urinary tract infection (Urinalysis before antibiotic therapy revealed significant leukocyturia (≥104) and direct examination revealed GPC)
- Known allergy to beta-lactam antibiotics
- Severe renal impairment (glomerular filtration rate <30 mL/min*1.73 m2)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Robert Debre Hospital
Paris, Ap-hp / DRCI, 75019
Gabriel LIGNIERES, MD, +331 40 03 53 61, GABRIEL.LIGNIERES@aphp.fr
Marion CASERIS, MD, +331 40 03 53 61, marion.caseris@aphp.fr
About this study
Temocillin, a 6-alpha-methoxypenicillin derivative of ticarcillin, is a narrow-spectrum antibiotic, primarily restricted to Enterobacterales. Therefore, its prescription for the treatment of febrile urinary tract infections requiring hospitalization in pediatrics appears interesting.
However, and despite marketing authorization in pediatrics for the treatment of complicated urinary tract infections (including acute pyelonephritis), the pharmacokinetic parameters of this antibiotic have not been specifically evaluated in pediatrics, and the optimal dose is not known in this population.
Through this study, we propose to determine the pharmacokinetic parameters of temocillin in children aged 0-15 years with a febrile urinary tract infection due to Gram-negative rod (GNR), without sepsis but requiring hospitalization. The results will help to establish dose recommendations for temocillin in the pediatric population, based on age and renal function.
Read the detailed description
Clinical Context of Temocillin Use:
Temocillin is an old antibiotic, a 6-alpha-methoxypenicillin derivative of ticarcillin, which has been rediscovered in recent years due to its narrow spectrum of activity and its ability to resist hydrolysis by most beta-lactamases, including ESBL. Temocillin is bactericidal, is not impacted by the inoculum effect, and has a low selection of resistant mutants. Due to its narrow spectrum (essentially limited to Enterobacterales), it appears to have a reduced overall impact on the fecal microbiota.
Studies have retrospectively reported clinical and microbiological efficacy of temocillin in urinary tract infections caused by ESBL-producing Enterobacterales in children and adults.
More generally, Enterobacterales have a high susceptibility to temocillin, with susceptibility rates exceeding 90-95% in several epidemiological studies in both children and adults. This is higher than that of third-generation cephalosporins, which still remain the first-line treatment in recent french guidelines (GPIP, SPILF), As a result, temocillin has been approved for the treatment of acute pyelonephritis (febrile urinary tract infections), including in the pediatric population. In France, it is primarily used for the treatment of ESBL-associated febrile urinary tract infections.
Since september 2024, Robert Debré University Hospital uses temocillin has an empiricial antibiotic therapy for hospitalized cases of febrile urinary tract infections, without any sign of sepsis, at the recommended high dose of 50 mg/kg/day in 2 intravenous injections of 30 min spaced 12 hours apart.
Pharmacokinetic Data of Temocillin:
Temocillin is a bactericidal antibiotic for parenteral use, belonging to the beta-lactam family. Temocillin binds strongly to plasma proteins (approximately 80% binding) and has a prolonged elimination half-life of approximately 5 hours. Its elimination is primarily renal.
As with other beta-lactams, the best pharmacokinetic/pharmacodynamic (PK/PD) criterion correlated with the efficacy of temocillin appears to be the cumulative percentage of time over 24 hours during which temocillin's free concentration exceeds the minimum inhibitory concentration (fT>MIC) at steady state. A target fT>MIC 40% of is associated with antibacterial effect and in vivo survival.
In adults, Monte Carlo pharmacokinetic simulations have demonstrated that an IV regimen of 2 grams every 12 hours allows a %ft>MIC of 40% to be achieved in 95% of treated patients and for MICs up to 8 mg/L.
In children up to 15 years of age, the standard recommended dosage is 25 mg/kg/day in 2 IV injections (max. 4g/day) but a higher dosage of 50 mg/kg/day in 2 IV injections (max. 4g/day) is indicated for the treatment of severe infections (including acute pyelonephritis requiring hospitalization). However, these proposed regimens recommendations do not originate from paediatric PK/PD studies but are derived from adult studies. To date, no study has evaluated the pharmacokinetic parameters of temocillin specifically in children (<15 years), and the optimal dosage regimen maximizing the probability of reaching the target PK/PD criterion (fT>MIC of 40%) in the treatment of febrile urinary tract infections due to GNR is currently unknown.
- Conditions
- Pyelonephritis
- Being tested
- blood samples
- Keywords
- temocillin
- Medical subject headings
- Pyelonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesOther
2 blood samples of 1 mL
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of the theoretical PK/PD target of 40% of the time spent above the MIC of the bacteria in question (fT>MIC=40%) for a temocillin dose of 50mg/kg/day in 2 IV injections of 30 min spaced 12h apart,
Achievement of the theoretical PK/PD target of 40% of the time spent above the MIC of the bacteria in question (fT>MIC=40%) for a temocillin dose of 50mg/kg/day in 2 IV injections of 30 min spaced 12h apart, on the population modellisation of the unbound plasma concentration of temocillin over 24h. Samples taken 1 hour after the start of a temocillin infusion then between 6 and 8 hours after the start of the infusion or sample taken 2 hours after the start of a temocillin infusion then between 10 and 12 hours after the start of the infusion
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Sep 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PyelonephritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel LIGNIERES, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070102
- Sponsor's protocol ID
- APHP241684
- Other IDs
- 2025-A00368-41
- Acronym
- TEMOKID-POP
- Status last verified
- Nov 2026
- First submitted
- 23 Jun 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
- ClinicalTrials.gov ID
- NCT07070102
- Acronym / sponsor ID
- TEMOKID-POP / APHP241684
- Conditions
- Pyelonephritis
- Keywords
- temocillin
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 17 Jul 2025 (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.
Temocillin, a 6-alpha-methoxypenicillin derivative of ticarcillin, is a narrow-spectrum antibiotic, primarily restricted to Enterobacterales. Therefore, its prescription for the treatment of febrile urinary tract infections requiring hospitalization in pediatrics appears interesting.
However, and despite marketing authorization in pediatrics for the treatment of complicated urinary tract infections (including acute pyelonephritis), the pharmacokinetic parameters of this antibiotic have not been specifically evaluated in pediatrics, and the optimal dose is not known in this population.
Through this study, we propose to determine the pharmacokinetic parameters of temocillin in children aged 0-15 years with a febrile urinary tract infection due to Gram-negative rod (GNR), without sepsis but requiring hospitalization. The results will help to establish dose recommendations for temocillin in the pediatric population, based on age and renal function.
Detailed description
Clinical Context of Temocillin Use:
Temocillin is an old antibiotic, a 6-alpha-methoxypenicillin derivative of ticarcillin, which has been rediscovered in recent years due to its narrow spectrum of activity and its ability to resist hydrolysis by most beta-lactamases, including ESBL. Temocillin is bactericidal, is not impacted by the inoculum effect, and has a low selection of resistant mutants. Due to its narrow spectrum (essentially limited to Enterobacterales), it appears to have a reduced overall impact on the fecal microbiota.
Studies have retrospectively reported clinical and microbiological efficacy of temocillin in urinary tract infections caused by ESBL-producing Enterobacterales in children and adults.
More generally, Enterobacterales have a high susceptibility to temocillin, with susceptibility rates exceeding 90-95% in several epidemiological studies in both children and adults. This is higher than that of third-generation cephalosporins, which still remain the first-line treatment in recent french guidelines (GPIP, SPILF), As a result, temocillin has been approved for the treatment of acute pyelonephritis (febrile urinary tract infections), including in the pediatric population. In France, it is primarily used for the treatment of ESBL-associated febrile urinary tract infections.
Since september 2024, Robert Debré University Hospital uses temocillin has an empiricial antibiotic therapy for hospitalized cases of febrile urinary tract infections, without any sign of sepsis, at the recommended high dose of 50 mg/kg/day in 2 intravenous injections of 30 min spaced 12 hours apart.
Pharmacokinetic Data of Temocillin:
Temocillin is a bactericidal antibiotic for parenteral use, belonging to the beta-lactam family. Temocillin binds strongly to plasma proteins (approximately 80% binding) and has a prolonged elimination half-life of approximately 5 hours. Its elimination is primarily renal.
As with other beta-lactams, the best pharmacokinetic/pharmacodynamic (PK/PD) criterion correlated with the efficacy of temocillin appears to be the cumulative percentage of time over 24 hours during which temocillin's free concentration exceeds the minimum inhibitory concentration (fT>MIC) at steady state. A target fT>MIC 40% of is associated with antibacterial effect and in vivo survival.
In adults, Monte Carlo pharmacokinetic simulations have demonstrated that an IV regimen of 2 grams every 12 hours allows a %ft>MIC of 40% to be achieved in 95% of treated patients and for MICs up to 8 mg/L.
In children up to 15 years of age, the standard recommended dosage is 25 mg/kg/day in 2 IV injections (max. 4g/day) but a higher dosage of 50 mg/kg/day in 2 IV injections (max. 4g/day) is indicated for the treatment of severe infections (including acute pyelonephritis requiring hospitalization). However, these proposed regimens recommendations do not originate from paediatric PK/PD studies but are derived from adult studies. To date, no study has evaluated the pharmacokinetic parameters of temocillin specifically in children (<15 years), and the optimal dosage regimen maximizing the probability of reaching the target PK/PD criterion (fT>MIC of 40%) in the treatment of febrile urinary tract infections due to GNR is currently unknown.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patient aged 0 to 15 years (inclusive) presenting with a febrile urinary tract infection with BGN requiring hospitalization in the departments of the Robert-Debré University Hospital for a duration of at least 48 hours
Key inclusion criteria (4 listed)
- Patient aged 0 to 15 years
- Presenting with a febrile urinary tract infection due to GNR (a febrile urinary tract infection is defined as a urine culture showing significant leukocyturia (≥104) and direct examination showing GNR, in a patient with fever)
- Requiring hospitalization in the general pediatrics, emergency (short-stay hospitalization unit), nephrology, or intensive care units of the Robert-Debré University Hospital for a presumed period of at least 48 hours.
- Non-opposition of the legal representatives obtained by one of the investigator
Key exclusion criteria (4 listed)
- Presence of sepsis (Phoenix score ≥ 2)
- Gram-positive cocci (GPC) urinary tract infection (Urinalysis before antibiotic therapy revealed significant leukocyturia (≥104) and direct examination revealed GPC)
- Known allergy to beta-lactam antibiotics
- Severe renal impairment (glomerular filtration rate <30 mL/min*1.73 m2)
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 |
|---|---|---|
| blood samples2 blood samples of 1 mL | Other | – |
Primary outcome
Achievement of the theoretical PK/PD target of 40% of the time spent above the MIC of the bacteria in question (fT>MIC=40%) for a temocillin dose of 50mg/kg/day in 2 IV injections of 30 min spaced 12h apart,
Time frame: 24 months
Achievement of the theoretical PK/PD target of 40% of the time spent above the MIC of the bacteria in question (fT>MIC=40%) for a temocillin dose of 50mg/kg/day in 2 IV injections of 30 min spaced 12h apart, on the population modellisation of the unbound plasma concentration of temocillin over 24h. Samples taken 1 hour after the start of a temocillin infusion then between 6 and 8 hours after the start of the infusion or sample taken 2 hours after the start of a temocillin infusion then between 10 and 12 hours after the start of the infusion
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 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
Gabriel LIGNIERES, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pyelonephritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 Nov 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 France. 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.
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 Gabriel LIGNIERES, MD (+331 40 03 53 61, GABRIEL.LIGNIERES@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of the theoretical PK/PD target of 40% of the time spent above the MIC of the bacteria in question (fT>MIC=40%) for a temocillin dose of 50mg/kg/day in 2 IV injections of 30 min spaced 12h apart, (time frame: 24 months). 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 6 Nov 2026.