E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Tuberculosis diagnostic tool |
Prueba diagnóstica para la tuberculosis |
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E.1.1.1 | Medical condition in easily understood language |
Tuberculosis diagnosis |
Diagnóstico de la tuberculosis |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10044755 |
E.1.2 | Term | Tuberculosis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 |
-To compare the diagnostic performance of C-Tb to that of QuantiFERON®-TB Gold In-Tube -To compare the diagnostic performance of C-Tb to that of Tuberculin PPD RT23 SSI -To assess the safety of C-Tb |
-Comparar la utilidad diagnóstica de C-Tb con la de QuantiFERON®-TB Gold In-Tube -Comparar la utilidad diagnóstica de C-Tb con la de Tuberculina PPD RT23 SSI -Evaluar la eficacia de C-Tb |
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E.2.2 | Secondary objectives of the trial |
To asses the diagnostic outcome of C-Tb, QuantiFERON®-TB Gold In-Tube and Tuberculin PPD RT23 SSI between and within 4 groups defined by estimated risk of infection with M. tuberculosis (MTb). |
Evaluar el resultado diagnóstico de C-Tb, QuantiFERON®-TB Gold In-Tube y Tuberculina PPD RT23 SSI en y entre 4 grupos definidos en función del riesgo estimado de infección por M. tuberculosis (MTb). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Can comply with one of the following groups: a) Negative control group: Must have no history of exposure to a TB index case, and have no signs or symptoms of TB b) Positive control group: Confirmed TB disease within the last 3 years by sputum smear microscopy and/or Culture, Gene Xpert or PCR c) Close contact group: Must be in close contact with a pulmonary smear positive TB index case for more than 6 hours/day for at least five days d) Occasional contact group: Must be in contact with a pulmonary sputum smear positive TB index case between 6 hours/week and 6 hours/day 2.Is between 6 weeks - 65 years of age 3.Participant, parent or legal guardian has provided signed informed consent 4.Is willing and likely to comply with the trial procedures 5.Is prepared to grant authorized persons access to their medical record |
1.Deberán cumplir los criterios para ser incluidos en uno de los siguientes grupos: a)Grupo de control negativo No deben presentar antecedentes de exposición a un caso inicial de TB, y tampoco deben mostrar signos o síntomas de TB. b)Grupo de control positivo: Deben haber padecido TB en el transcurso de los 3 años previos, confirmada mediante microscopia y/o cultivo de frotis de esputo, PCR o el sistema Gene Xpert. c) Grupo de contacto estrecho: Deben haber mantenido contacto estrecho con un caso inicial de TB pulmonar (resultados positivos en la prueba de frotis de esputo), durante más de 6 horas/día, al menos durante cinco días. d) Grupo de contacto ocasional: Deben haber mantenido contacto estrecho con un caso inicial de TB pulmonar (resultados positivos en la prueba de frotis de esputo) (entre 6 horas/semana y 6 horas/día). 2.Deben tener entre 6 semanas y 65 años de edad. 3.Deben haber proporcionado el consentimiento informado por escrito (también podrán proporcionarlo los padres o el representante legal, según corresponda). 4.Deben estar dispuestos a realizar los procedimientos del estudio. 5.Deben otorgar su permiso para que las personas autorizadas tengan acceso a su historia clínica. |
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E.4 | Principal exclusion criteria |
1.Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. Mumps Measles Rubella (MMR), yellow fever, oral typhoid vaccines) 2.Has been tuberculin tested less than 12 months prior to the day of inclusion 3.Is pregnant, breastfeeding or intending to get pregnant within the trial period 4.Is a female of child bearing potential (12 years of age or older having had their first menstruation) not willing to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptive measures within the trial period 5.Has an active disease affecting the lymphoid organs except for HIV (e.g., Hodgkin?s disease, lymphoma, leukaemia, sarcoidosis) 6.Has a current skin condition which interferes with the reading of the C-Tb and Tuberculin PPD RT23 SSI e.g. tattoos, severe scarring, burns/sunburns, rash, eczema, psoriasis, or any other skin disease at or near the injection sites 7.Has a condition where blood drawings pose more than minimal risk for the participant, such as haemophilia, other coagulation disorders, or significantly impaired venous access 8.Current participation in another clinical trial with an investigational or non investigational drug or device, which in the opinion of investigator may interfere with this trial drug 9.Has participated in previous clinical trials investigating injections with ESAT-6 and/or CFP-10 antigens 10.Has a condition which in the opinion of the investigator is not suitable for participation in the trial |
1.Haber recibido una vacuna viva en el transcurso de las 6 semanas previas al día de inclusión en el estudio (por ejemplo, paperas, sarampión, rubeola, fiebre amarilla, vacunas orales frente a la fiebre tifoidea) 2.Haberse sometido a la prueba de tuberculina menos de 12 meses antes del día de la inclusión en el estudio. 3.Estar embarazada o en período de lactancia, o tener intención de quedarse embarazada durante el estudio. 4.En el caso de las mujeres en edad fértil (? 12 años de edad, que hayan tenido la primera menstruación), no estar dispuestas a utilizar un método anticonceptivo eficaz (hormonal, intrauterino o de barrera [incluido el gel espermicida]) durante el estudio. 5.Padecer una enfermedad activa que afecte a los órganos linfáticos (con la excepción de VIH) ?por ejemplo, enfermedad de Hodgkin, linfoma, leucemia, sarcoidosis?. 6.Presentar alguna enfermedad cutánea que interfiera con la lectura de las pruebas de C-Tb y Tuberculina PPD RT23 SSI (por ejemplo, tatuajes, cicatrizaciones graves, quemazón / quemadura solar, exantema, eccema, psoriasis o cualquier otra enfermedad cutánea en la zona de inyección o cerca de esta). 7.Padecer alguna enfermedad por la que las extracciones de sangre representen más que un riesgo mínimo para el participante, como hemofilia, otros trastornos de la coagulación o acceso venoso significativamente deteriorado. 8.Estar participando en la actualidad en otro ensayo clínico con un fármaco o dispositivo autorizados o en fase de investigación que, en opinión del investigador, podrían interferir con el fármaco de este estudio. 9.Haber participado previamente en ensayos clínicos en los que se evaluara la administración de inyecciones con antígenos ESAT-6 y/o CFP-10. 10.Padecer una enfermedad que en opinión del investigador haga que el participante no se considere idóneo para ser incluido en el estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
-The specificity of C-Tb compared to that of QuantiFERON®-TB Gold In-Tube -The specificity of C-Tb compared to that of Tuberculin PPD RT23 SSI -The sensitivity of C-Tb compared to that of QuantiFERON®-TB Gold In-Tube -The sensitivity of C-Tb compared to that of Tuberculin PPD RT23 SSI |
-Especificidad de C-Tb en comparación con la de QuantiFERON®-TB Gold In-Tube -Especificidad de C-Tb en comparación con la de Tuberculina PPD RT23 SSI -Sensibilidad de C-Tb en comparación con la de QuantiFERON®-TB Gold In-Tube -Sensibilidad de C-Tb en comparación con la de Tuberculina PPD RT23 SSI |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Reading of indurantion at 48-72 hours Quantiferon results: when available |
Lectura de la induración a las 48-72 horas Resultados del Quantiferon: cuando estén disponibles |
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E.5.2 | Secondary end point(s) |
-Response ratios for C-Tb, QuantiFERON®-TB Gold In-Tube and Tuberculin PPD RT23 SSI in 4 groups defined by estimated risk of infection with MTb. -The diameter of induration at the C-Tb injection site measured transversely to the long axis of the forearm at 2 to 3 days after intradermal administration of C-Tb -The diameter of induration at the Tuberculin PPD RT23 SSI injection site measured transversely to the long axis of the forearm at 2 to 3 days after intradermal administration of Tuberculin PPD RT23 SSI |
-Cocientes de respuesta para C-Tb, QuantiFERON®-TB Gold In-Tube y Tuberculina PPD RT23 en 4 grupos definidos en función del riesgo estimado de infección por MTb. -Diámetro de la induración en la zona de inyección de C-Tb, medido transversalmente al eje mayor del antebrazo, 2-3 días después de la administración intradérmica de C-Tb. -Diámetro de la induración en la zona de inyección de Tuberculina PPD RT23 SSI, medido transversalmente al eje mayor del antebrazo, 2-3 días después de la administración intradérmica de Tuberculina PPD RT23 SSI. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Reading of indurantion at 48-72 hours Quantiferon results: when available |
Lectura de la induración a las 48-72 horas Resultados del Quantiferon: cuando estén disponibles |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
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 | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 12 |
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 | Yes |
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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Last Patient Last Visit |
Ultima Visita del Último Paciente |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 28 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 28 |