E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
proven or suspected sepsis, lower respiratory tract infection, complicated intraabdominal infection |
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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 describe the pharmacokinetic profile of the first meropenem dose of the presently recommended intravenous dose of meropenem given as a continuous infusion over 4 hours or as a bolus injection over 30 minutes in very low birth weight infants
To describe the safety of the presently recommended intravenous dose when given as a continuous infusion over 4 hours or as a bolus injection over 30 minutes in very low birth weight infants |
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E.2.2 | Secondary objectives of the trial |
to descibe safety of meropenem in very low birth weight neonates |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Gestational age of ≤ 32 weeks and birth weight below 1500 grams; 2. Postnatal age of ≤ 56 days 3. Written consent signed by parents or legal representatives 4. Required hospitalisation into intensive care unit 5. Arterial or venous cannula settled for clinical reasons 6. Need for meropenem treatment on following clinical indications: a. Proven or suspected sepsis, lower respiratory tract infection, complicated intraabdominal infection b. Clinical deterioration with symptoms suggesting worsening of infection during antibacterial treatment used for empiric treatment of EOS c. Isolation of bacteria from normally sterile sites known to be or suspected to be resistant to presently used antibiotics but susceptible to meropenem d. Suspected infection with multi-resistant bacteria, that is in-ward at same time patient with multiresistant bacteria 7. Expected not to die within 24 hours 8. No major uncorrected congenital malformations
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E.4 | Principal exclusion criteria |
1. Patients with gestational age > 32 weeks and birth weight > 1500 grams; 2. Patients with postnatal age > 56 days 3. Written consent not signed by parents or legal representative 4. Arterial or venous cannula not settled for clinical reasons 5. Patients not needing meropenem treatment 6. Patients expected to die within 24 hours 7. Patients with major uncorrected congenital malformations 8. Patients participating in other studies of investigational agents
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E.5 End points |
E.5.1 | Primary end point(s) |
1.AUC- area under the plasma concentration-time curve during a dosing interval 2.T1/2- plasma concentration half-life 3.Clt- total body clearance 4.Clr-renal clearance 5.Vd- volume of distribution 6.Cmax-maximal concentration during a dosing interval |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | 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 | Yes |
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 | 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
| 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 | 2 |
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 | 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
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End of trial is 1.February 2012 or before if planned number of patients will be recruited earlier |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |