E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Suspected or proven bacterial infection requiring therapy with broad spectrum antibiotics |
Vermutete oder bewiesene bakterielle Infektion die eine Behandlung mit antibakterieller Breitspektrum-Therapie erforderlich macht |
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E.1.1.1 | Medical condition in easily understood language |
Suspected or proven bacterial infection requiring intravenous therapy with broad spectrum drugs against bacteria |
Vermutete oder bewiesene bakterielle Infektion die eine Behandlung mit Breitspektrum Medikamenten gegen Bakterien erforderlich macht |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042196 |
E.1.2 | Term | Streptococcus pneumoniae secondary bacterial infection of acute bronchitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053021 |
E.1.2 | Term | Gram-positive bacterial infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10035649 |
E.1.2 | Term | Pneumococcal secondary bacterial infection of acute bronchitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004038 |
E.1.2 | Term | Bacterial infection due to streptococcus, group C |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004039 |
E.1.2 | Term | Bacterial infection due to streptococcus, group D |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004031 |
E.1.2 | Term | Bacterial infection due to other gram-negative organisms |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10004047 |
E.1.2 | Term | Bacterial infections NEC |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 | 10060945 |
E.1.2 | Term | Bacterial infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004042 |
E.1.2 | Term | Bacterial infection due to unspecified streptococcus |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004037 |
E.1.2 | Term | Bacterial infection due to streptococcus, group B |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054278 |
E.1.2 | Term | Bacterial infection due to streptococcus, group F |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004041 |
E.1.2 | Term | Bacterial infection due to unspecified staphylococcus |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004036 |
E.1.2 | Term | Bacterial infection due to streptococcus, group A |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004044 |
E.1.2 | Term | Bacterial infection NOS |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004035 |
E.1.2 | Term | Bacterial infection due to staphylococcus aureus |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004040 |
E.1.2 | Term | Bacterial infection due to streptococcus, group G |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018657 |
E.1.2 | Term | Gram-negative bacterial infection NOS |
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 |
Measuring pharmakokinetecs of ampicillin / sulbactam and amoxicillin / clavulanic acid during haemodialysis |
Messen der Pharmakokinetik von Ampicillin / sulbactam und Amoxicillin / Clavulansäure während der Hämodialyse |
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E.2.2 | Secondary objectives of the trial |
Comparison of development of liver enzyme serum levels during therapy with both drug combinations |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
a) Age >18 years b) Suspected or proven bacterial infection requiring parenteral antibiotic therapy. c) Organ replacement therapy (HD)
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E.4 | Principal exclusion criteria |
a) Known hypersensitivity to ampicillin / sulbactam, amoxicillin / clavulanic acid or other beta-lactames, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents. b) An expected survival of less than two days. c) Known pregnancy d) Co-administration of one of the following drugs: - probenecid which cannot be discontinued for the duration of the study e) Ampicillin / sulbactam respectively amoxicillin / clavulanic acid as monotherapy for resistant species or fungal infections. f) Other reasons opposing the study participation on the discretion of the investigators.
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E.5 End points |
E.5.1 | Primary end point(s) |
Pharmacokinetics of ampicillin / sulbactam and amoxicillin / clavulanic acid in haemodialysis: area under the curve (AUC), half-life (t1/2), maximum and minimum plasma concentration (Cmax, Cmin), total body clearance (Cltot), hemofiltration clearance (ClHF), sieving coefficient and the elimination fraction. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
0, 0.5, 1, 2, 3.5 and 4 hours post infusion on day hemodialysis day 2 (HD2), and 0, 0.5 and 1 hour post infusion on HD3 to 7 |
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E.5.2 | Secondary end point(s) |
elevation of liver enzymes (gamma-GT, ASAT, ALAT, aP) under both therapies |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
assessment of selected side effects (liver enzyme elevation) |
|
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) | 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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.5 | 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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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 | 24 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 24 |
E.8.9.2 | In all countries concerned by the trial days | 0 |