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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001486-15 |
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The main objective of the study is to comparatively assess the efficacy and tolerability of the drugs under study in the treatment of acute uncomplicated cystitis.
Urinary tract infections (UTI) are one of the most frequent reasons of surgery visits in Primary Care. More than 95 percent of UTIs are monomicrobial, although the microorganisms implied are varied, and the range of effective drugs could be extensive. The species most frequently isolated is Escherichia coli, with prevalence ranking between 85 and 90 percent of documented cases. E. coli has developed resistance to different antibiotics. Cefditoren is situated as a good candidate for the treatment of uncomplicated UTIs due to its spectrum of activity against E. coli. The study has been designed in accordance with the guidelines and recommendations in force to assess the efficacy of cefditoren pivoxil against ciprofloxacin, a drug which despite the increasing rate of resistance in some countries, continues to be a drug of choice for the treatment of uncomplicated UTIs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Cefditoren pivoxil |
|
| 2 | Active Comparator | Ciprofloxacin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cefditoren pivoxil | Drug | 400 mg, oral, single dose during 3 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological efficacy | 5-9 days post-therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical efficacy | 5-9 days post-therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose L Ballve | Principal Investigator | |
| Josep R Toll | Principal Investigator | |
| Rosa Viñas | Principal Investigator | |
| Rosaura Figueras | Principal Investigator | |
| Joan Palou | Principal Investigator | |
| Gabriel Martín | Principal Investigator | |
| Ramon Pons | Principal Investigator | |
| Manel Terns | Principal Investigator | |
| Josep L Fernandez | Principal Investigator | |
| Pere Toran | Principal Investigator | |
| Pilar Montero |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Chest Disease of Athens | Athens | Greece | ||||
| General Hospital of Thessaloniki |
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| Ciprofloxacin | Drug | 250 mg, oral, twice a day for 3 days |
|
|
| Principal Investigator |
| Bingen Uriondo | Principal Investigator |
| Pablo Daza | Principal Investigator |
| Jesus Zorita | Principal Investigator |
| Ander Larrazabal | Principal Investigator |
| Natividad Gonzalez | Principal Investigator |
| Jose F Magdalena | Principal Investigator |
| Fernando Martin | Principal Investigator |
| Jose Porta | Principal Investigator |
| Mª Rosa Magallon | Principal Investigator |
| Mª Sol Reixa | Principal Investigator |
| Jesus Torrecilla | Principal Investigator |
| Isabel Blasco | Principal Investigator |
| Antonio Hidalgo | Principal Investigator |
| Alicia Alvarez | Principal Investigator |
| Gabriel Romera | Principal Investigator |
| Estrella Castro | Principal Investigator |
| Manuel M Ortega | Principal Investigator |
| Salvador Pertusa | Principal Investigator |
| Manuel Ramirez | Principal Investigator |
| Aggelos Pefanis | Principal Investigator |
| Chatzimouratidis | Principal Investigator |
| Jose V Vaquer | Principal Investigator |
| Nicolas Salvador | Principal Investigator |
| Jose L Pardo | Principal Investigator |
| Joaquin Aracil | Principal Investigator |
| Mª Jesus Barreda | Principal Investigator |
| Artemio Alvarez | Principal Investigator |
| Vicente Lopez | Principal Investigator |
| Panagiotis Gargalianos | Principal Investigator |
| Dolores M Maestre | Principal Investigator |
| Thessaloniki |
| Greece |
| CS Rincón de Loix | Benidorm | Alicante | 03500 | Spain |
| CAP Cornella | Cornellà de Llobregat | Barcelona | 08940 | Spain |
| CAP 17 setembre | el Prat de Llobregat | Barcelona | 08820 | Spain |
| CAP Bartomeu Fabres Anglada | Gavà | Barcelona | 08850 | Spain |
| CAP Amadeu Torner | L'Hospitalet de Llobregat | Barcelona | 08902 | Spain |
| CAP Florida Nord | L'Hospitalet de Llobregat | Barcelona | 08905 | Spain |
| CAP Dr. Vicens Papaceit | La Roca del Vallès | Barcelona | 08430 | Spain |
| CAP Les Bases-Manresa 3 | Manresa | Barcelona | 08243 | Spain |
| CAP La Riera | Mataró | Barcelona | 08302 | Spain |
| CAP El Maresme | Mataró | Barcelona | 08303 | Spain |
| CAP Navas-Balsareny | Navàs | Barcelona | 08670 | Spain |
| CAP Remei | Vic | Barcelona | 08500 | Spain |
| CS San Telmo | Jerez de la Frontera | Cadiz | 11408 | Spain |
| CS Cabra | Cabra | Cordoba | 14940 | Spain |
| CS Lucena | Lucena | Cordoba | 14900 | Spain |
| CS Rute | Rute | Cordoba | 14960 | Spain |
| CS Billabona | Billabona | Guipuzcoa | 20150 | Spain |
| CS Legazpi | Legazpi | Guipuzcoa | 20230 | Spain |
| CS Monzón Urbano | Monzón | Huesca | 22400 | Spain |
| CS Basurto | Bilbao | Vizcaya | 48013 | Spain |
| CS Cabo Huertas | Alicante | 03540 | Spain |
| CAP El Clot | Barcelona | 08018 | Spain |
| Fundacion Puigvert | Barcelona | 08025 | Spain |
| CS Sagasta Ruiseñores | Zaragoza | 50006 | Spain |
| CS Torrero La Paz | Zaragoza | 50007 | Spain |
| CS Torre Ramona | Zaragoza | 50013 | Spain |
| CS Arrabal | Zaragoza | 50015 | Spain |
| CS Bombarda | Zaragoza | 50017 | Spain |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D003556 | Cystitis |
| 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 |
| D001745 | Urinary Bladder Diseases |
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| ID | Term |
|---|---|
| C057710 | cefditoren pivoxil |
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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