E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037440 |
E.1.2 | Term | Pulmonary tuberculosis |
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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 determine whether adjunctive vitamin D enhances response to standard antibiotic therapy for pulmonary tuberculosis |
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E.2.2 | Secondary objectives of the trial |
To determine whether adjunctive vitamin D modulates host response to standard antibiotic therapy for pulmonary tuberculosis
To determine whether administration of adjunctive vitamin D at the proposed dosage is safe and well-tolerated in patients taking standard treatment for pulmonary tuberculosis
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age 18 years or older Suspected pulmonary tuberculosis (with or without extrapulmonary tuberculosis) with acid-fast bacilli in a stained sputum smear If a woman of child-bearing potential, has negative pregnancy test and agrees to use reliable form of contraception for at least 8 months Willing and able to travel to Homerton Hospital TB Clinic for sputum induction if necessary, and contactable by telephone Gives written informed consent to participate
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E.4 | Principal exclusion criteria |
Known intolerance of vitamin D or first-line anti-tuberculous therapy Known sarcoidosis, hyperparathyroidism or nephrolithiasis Taking benzothiadiazine derivatives or cardiac glycosides Specific comorbidity (known malignancy, known liver failure, known renal failure, known pulmonary silicosis, known HIV infection) Taking oral corticosteroid therapy, immuno-suppressant therapy or cytotoxic drug in the month preceding enrollment Taking antituberculous therapy for more than 7 days in the 6 months preceding enrolment Taking antituberculous therapy other than rifampicin, isoniazid, pyrazinamide and ethambutol at time of enrollment Infection with rifampicin-resistant organism (as demonstrated by rapid molecular testing) Serum corrected calcium >2.66 mmol/l Serum AST >3 x ULN Total serum bilirubin > 2.5 x ULN Serum creatinine > 2 x ULN Breastfeeding Planned travel out of London area within 8 weeks of enrollment
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E.5 End points |
E.5.1 | Primary end point(s) |
Time from initiation of standard antituberculous therapy to sputum culture conversion |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
E.8.2.3 | Other | No |
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 | Information not present in EudraCT |
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 follow-up visit of last trial participant. The trial will end when 146 patients are recruited, or earlier if a statistically significant (p<0.01) difference in time to culture conversion or rate of fatal/life-threatening adverse events is demonstrated between intervention and control groups at interim analyses (safety analyses performed 6-monthly; efficacy analysis performed after enrollment of 73 patients) |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |