E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Abscess and anal fistulas |
Abscesos y fístulas perianales |
|
E.1.1.1 | Medical condition in easily understood language |
Abscess and anal fistulas |
Abscesos y fístulas perianales |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Microbiological Phenomena [G06] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Demonstrate that oral antibiotic after perianal abscess debridement decreases the anal fistula incidence |
Demostrar que la antibioterapia oral posterior al desbridamiento de un absceso perianal disminuye la incidencia de fístulas perianales crónicas. |
|
E.2.2 | Secondary objectives of the trial |
Show the clinical benefit (quality of life included) of oral antibiotic after perianal abscess debridement in development of anal fistula Describe the pacients under risk of anal fistulas aparition after anal abscess episode. |
Estudiar los beneficios clínicos (incluida la calidad de vida) de una terapia antibiótica oral después del drenaje de un absceso perianal en el desarrollo de fístula anal. Describir qué pacientes están en riesgo de desarrollar una fístula anal después de un episodio de absceso perianal. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
18 years or more Both genders Clinical diagnosis of anal abscess (acute inflammatory signs and presence of a purulent collection in the perianal area) seen or confirmed through punction aspiration of purulent material with needle. |
Pacientes mayores de 18 años Pacientes de ambos sexos Tener diagnóstico clínico de absceso perianal (signos inflamatorios agudos y presencia de una colección purulenta en la zona perianal) evidenciado por visualización directa de una zona fluctuante o aspiración de contenido purulento a través de la punción con jeringa y aguja. |
|
E.4 | Principal exclusion criteria |
Inflammatory bowel disease Anal surgical history Anal fistula alredy konwn Anal carcinoma and/or pelvic radiotherapy Anal trauma history "horse shoe" abscess Inmunodeficiency, diabetes, pregnancy or lactation, heart valve disease or prosthetic valve carriers Spontaneous drainage of abscess Antibiotics use Contraindications of ciprofloxacin according to SPC (hypersensitivity to the active principle, or to other quinolones or to any of the excipients; concomitant administration of ciprofloxacin and tizanidine) - Contraindications of metronidazole according to SPC (hypersensitivity to imidazoles or to any of the excipients) -Pregnancy and lactation |
Pacientes portadores de Enfermedad Inflamatoria Intestinal Pacientes con antecedentes quirúrgicos en la zona perianal Pacientes que ya posean una fístula perianal Pacientes con cáncer perianal y/o radioterapia pélvica Antecedente de traumatismo perianal Abscesos que crucen la línea media Pacientes con inmunodeficiencias, diabetes, embarazo o lactancia, enfermedad valvular cardíaca o portadores de válvula protésica Pacientes que hayan presentado drenaje espontáneo Uso previo de antibióticos - Contraindicaciones de ciprofloxacino según ficha técnica (hipersensibilidad al principio activo, o a otras quinolonas o a alguno de los excipientes; administración concomitante de ciprofloxacino y tizanidina) - Contraindicaciones de metronidazol según ficha técnica (hipersensibilidad a los imidazoles o a alguno de los excipientes) -Embarazo y lactancia |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Fistula anal presence (Parks classification) |
Presencia de fístula anal (clasificación de Parks) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1st month 3rd month 6th month 9th month |
1er mes 3er mes 6to mes 9no mes |
|
E.5.2 | Secondary end point(s) |
Ultrasonography to fistula examination |
Ultrasonografía para evaluar fístulas perianales |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Evaluation done by a third part |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |