E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
community aquired pneumonia |
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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 |
To evaluate the efficacy and tolerability of intravenously administered azithromycin given as a 1.5 g single dose compared to 500 mg daily dose over a period of 3 days in patients suffering from community-acquired pneumonia. If azithromycin treatment administered intavenously as a 1.5 g dose can be proven therapeutically equivalent or not inferior to 500 mg administered intravenously over a period of 3 days, treatment of CAP patients can be optimised. This short regimen has the potential for enhancement of patient compliance and will lead to a reduction of costs because of minimisation of hospitalisation days. It even provides the possibility of outpatient treatment administration in patients with minor compliance. |
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E.2.2 | Secondary objectives of the trial |
Microbiological cure/failure, frequency of adverse events, death, additionally required therapeutic measures and dynamics of x-ray findings will be evaluated
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Female or male, aged between 18 and 90 years, who achieve the criteria of risk classes II – IV after the scoring system of Bartlett et al. (Clin. Infectious Diseases 2000) (17). • Written informed consent. • Chest radiograph showing a new pulmonary infiltrate and two or more of the following clinical data: fever > 38°C, cough, dyspnea (respiratory rate over 20/min), elevated C-reactive protein or elvated (>10 G/L) or leukopenia (< 4 G/L) ,signs of consolidation on respiratory auscultation and a purulent sputum.
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E.4 | Principal exclusion criteria |
• Pregnancy or lactation. • Hemodialysis or hemofiltration. • Impaired hepatic function with arised liver parameters. • Allergy or hypersensitivity against study drugs. • Nosocomial pneumonia • Already hospitalized patients with pneumonia • Severe asthma or cystic fibrosis • Immunosuppression or asplenia • Previous participation in a study in the last 6 weeks • Known or suspected current infection that requires treatment with (an) additional anti-bacterial agent(s). • Concurent medication like ergotamine, theophylline or digitalis. • Achieving the criteria of risk group V after the scoring systemof Bartlett et.al.
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E.5 End points |
E.5.1 | Primary end point(s) |
For the evaluation of clinical efficacy, outcome is defined as clinical cure, failure or indeterminate. Efficacy will be evaluated in both study groups.
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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 | No |
E.6.5 | Efficacy | Yes |
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 | Information not present in EudraCT |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
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) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
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.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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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after inclusion of 300 patients with cap |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |