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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001257-14 | EudraCT Number |
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| Name | Class |
|---|---|
| Fondation Hôpital Saint-Joseph | OTHER |
| French National Network of Clinical Research in Infectious Diseases (RENARCI) | OTHER |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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TEMO-CARB is a phase 3, randomized, controlled, multicentre, open-label pragmatic clinical trial to test the non-inferiority of temocillin versus carbapenem as initial intravenous treatment of Urinary Tract Infection (UTI) due to extended-spectrum beta-lactamase (ESBL) producing enterobacteriaceae.
Urinary tract infections are among the most common bacterial infections that are treated in the community by an empirical antibiotic treatment regimen. Enterobacteriaceae are the most common bacteria involved in urinary tract infection. Since 2006, extended-spectrum beta-lactamase (ESBL) producing enterobacteriaceae have spread in France, as elsewhere. Finding therapeutic alternatives to carbapenems in infections caused by ESBL producing enterobacteriaceae is imperative. Although temocillin, 6-α-methoxy derivative of ticarcillin has been suggested as a potential alternative to carbapenem therapy for ESBL related infections, it was not investigated in accordance with current standard. The hypothesis to test in this study is that temocillin is not inferior to a carbapenem as initial intravenous treatment of urinary tract infections caused by ESBL producing enterobacteriaceae.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous temocillin | Experimental | Intravenous temocillin 2g/intravenously/8h or renally adjusted equivalent (ORAE) in 30-40 min infusion or continuous intravenous (6g/24h) |
|
| Intravenous meropenem or imipenem | Active Comparator | Intravenous meropenem or imipenem 1g/Intravenously /8h ORAE in 15-30 min infusion. Then switch to oral therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temocillin | Drug | Intravenous temocillin disodium 2g intravenously/8h Or Renally Adjusted Equivalent (ORAE) in 30-40 min infusion or continuous intravenous (6g/24h) . |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical and microbiological cure | The primary endpoint, was defined as achieving both clinical cure and microbiological eradication of all baseline pathogens 5-7 days after completion of treatment. Clinical cure is defined as complete resolution, substantial improvement or return to pre-infections signs and symptoms of complicated lower urinary tract infections or pyelonephritis without the need for additional antibiotic therapy Microbiological efficacy will be assessed by quantitative urine culture and defined as follows < 10^3 Colony Forming Unit (CFU)/mL of the baseline pathogens | 5-7 days after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Early microbiological eradication | Microbiological eradication will be assessed by quantitative urine culture and defined as follows < 10^3 colony forming unit Colony Forming Unit (CFU)/mL of the baseline pathogens | 3-4 days after randomization |
| Frequency of oral antibiotic switch in both arms (temocillin vs. carbapenem) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benoit PILMIS, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Olivier LORTHOLARY, MD, PhD | Assistance Publique - Hôpitaux de Paris | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Martinique | Fort-de-france | Martinique | France | |||
| CHRU La Cavale Blanche |
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| meropenem or imipenem | Drug | Intravenous carbapenem (meropenem 1g intravenously/8h Or Renally Adjusted Equivalent (ORAE) or imipenem 1g intravenously/8h ORAE) |
|
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| 60 days after randomization |
| Length of hospital stay | Time from randomization to hospital discharge | 60 days after randomization |
| Persistent cure rate | Clinical cure is defined as complete resolution, substantial improvement or return to pre-infections signs and symptoms of complicated lower urinary tract infections or pyelonephritis without the need for additional antibiotic therapy | 60 days after randomization |
| Clinical recurrences | Relapse: new symptoms of urinary tract infection in a patient previously considered as clinically or microbiologically cured in the visit 5-7 days after treatment completion plus positive urine ± blood culture grows the same microorganism isolated that in the initial culture. Re-infection: same definition but with different strain in urinary culture | 60 days after randomization |
| Mortality | Death for any reason or for infectious events | 60 days after randomization |
| Pharmacokinetic of temocillin according to kidney function | Description of the temocillin plasma concentration and its variability among patients | 3 days after treatment initiation |
| Microbiota impact study | Study treatment impact in the gut colonization with multidrug Gram negative bacilli) and temocillin resistant Gram negative bacilli | Time Frame : 5-7 days after treatment completion |
| Brest |
| 29000 |
| France |
| CHU de Grenoble Hospital | Grenoble | France |
| Melun Hospital - CHU Sud | Melun | 77 | France |
| APHP - Cochin Hospital | Paris | 75014 | France |
| APHP - Necker-Enfants maladies Hospital | Paris | 75015 | France |
| Bichat hospital | Paris | 75018 | France |
| Groupe Hospitalier Diaconesses Croix Saint Simon | Paris | 75020 | France |
| Tenon Hospital | Paris | 75020 | France |
| APHP - Beaujon Hospital | Paris | France |
| APHP - Georges Pompidou European Hospital | Paris | France |
| APHP - Saint-Antoine Hospital | Paris | France |
| Saint-Joseph Hospital | Paris | France |
| CHU de Pau | Pau | France |
| CHU de Poitiers | Poitiers | France |
| CHU Pontchaillou | Rennes | 35000 | France |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C031367 | temocillin |
| D000077731 | Meropenem |
| D015378 | Imipenem |
| D015780 | Carbapenems |
| ID | Term |
|---|---|
| D013845 | Thienamycins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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