E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Tratamiento de infecciones causadas por gérmenes sensibles. |
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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 |
Evaluar la eficacia terapéutica y seguridad de una pauta de 2 g de amoxicilina administrada en dosis única, por vía oral, 1 hora antes de la intervención, en la prevención de infecciones postquirúrgicas post cirugía de implantes simple. |
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E.2.2 | Secondary objectives of the trial |
Valorar la aparición de infecciones oportunistas tras administración de una pauta de 2 g de amoxicilina administrada en dosis única. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Sujetos de ambos sexos con edades comprendidas entre los 18 y los 75 años de edad. Requerir cirugía simple de implantes sin injertos (implante unitario). Calidad de hueso II-III valorado mediante BTI-SCAN. Posibilidad para observación durante el periodo de tratamiento. Aceptación libre de participar en el ensayo, con consentimiento informado por escrito.
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E.4 | Principal exclusion criteria |
Alergia a betalactámicos. Infecciones locales o sistémicas concurrentes que requieran tratamiento antibiótico. Calidad de hueso IV-V. Padecer enfermedades sistémicas que contraindiquen la intervención: cardiovasculares (valvulopatías, enfermedad coronaria, insuficiencia cardiaca), respiratorias (insuficiencia respiratoria), hematológicas (anemia, discrasias sanguíneas, hemofilia, agranulocitosis) metabólicas (diabetes) óseas (osteoporosis, osteomalacia, osteogénesis imperfecta, enfermedad de Paget), colagenosis (esclerodermia, síndrome de Sjögren, artritis reumatoide, lupus ), inmunodeficiencias, insuficiencia renal. Irradiación cérvico-facial > 5.000 rads.
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E.5 End points |
E.5.1 | Primary end point(s) |
Variables demográficas y de identificación: nº paciente, nº historia, edad, sexo Variables clínicas: Tabaco, antecedentes de los pacientes, salud bucodental, localización de los implantes, tipo de hueso. Variables de eficacia: Variable principal: nº de infecciones postquirúrgicas aparecidas en el periodo de seguimiento. Variables secundarias: grado de perdida ósea, tipo de epitelización, supervivencia del implante al final del seguimiento. Variables de seguridad: Recogida de gérmenes oportunistas y posibles acontecimientos adversos. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |