E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Necrotizing Soft Tissue Infections |
Nekrotiserende bløddelsinfektioner |
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E.1.1.1 | Medical condition in easily understood language |
Infections of the skin, subcutis, fat and/or muscle with necrosis |
Infektioner i hud, underhud, fedt- og/eller muskelvæv med nekrose |
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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 | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10055648 |
E.1.2 | Term | Necrotizing fasciitis fungal |
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 | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10052892 |
E.1.2 | Term | Necrotising fasciitis fungal |
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 | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10055647 |
E.1.2 | Term | Necrotizing fasciitis |
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 | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10055649 |
E.1.2 | Term | Necrotizing fasciitis staphylococcal |
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 | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10017068 |
E.1.2 | Term | Fournier's gangrene |
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 | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028885 |
E.1.2 | Term | Necrotising fasciitis |
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 | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016229 |
E.1.2 | Term | Fasciitis necrotising |
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 | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028886 |
E.1.2 | Term | Necrotising fasciitis 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 | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028888 |
E.1.2 | Term | Necrotising fasciitis streptococcal |
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 | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028887 |
E.1.2 | Term | Necrotising fasciitis staphylococcal |
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 | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10055650 |
E.1.2 | Term | Necrotizing fasciitis streptococcal |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10055643 |
E.1.2 | Term | Fasciitis necrotizing |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To estimate the effect of intravenous, polyspecific immunoglobulin G compared with placebo on the patient reported outcome measure Physical Component Summary Score (PCS) of the Short Form-36 (SF-36) in patients with necrotizing soft tissue infections. |
At estimere effekten af intravenøs, polyspecifik immunoglobulin G, sammenlignet med placebo, på det patient rapporterede outcome "Physical Component Summary Score" (PCS) fra Short Form-36 (SF-36) på patienter med nekrotiserende bløddelsinfektioner. |
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E.2.2 | Secondary objectives of the trial |
To estimate the frequency of serious adverse reactions for intravenous, polyspecific immunoglobulin G in patients with necrotizing soft tisse infections. |
At estimere antallet af alvorlige bivirkninger ved brug af intravenøs, polyspecifik immunoglobulin G til patienter med nekrotiserende bløddelsinfektioner. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Necrotizing soft tissue infection based on surgical findings Age >=18 years Admitted to or planned to be admitted to the ICU at Copenhagen University Hospital, Rigshospitalet
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Nekrotiserende bløddelsinfektion, baseret på de kirurgiske fund Alder >= 18 år Indlagt eller planlagt indlagt på ITA, Rigshospitalet
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E.4 | Principal exclusion criteria |
• >48 hour from the primary diagnosis to arrival at Copenhagen University Hospital, Rigshospitalet • More than one dose of intavenous, polyspecific immunoglobulin G (IVIG) given within current admission • Known hypersensitivity to IVIG • Hyperprolinaemia • Pregnancy or breast feeding
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• >48 fra primære diagnose til ankomst på Rigshoapitalet • Mere end én dosis intravenøs, polyspecifikt immunoglobulin G (IVIG) givet i forbindelse med denne indlæggelse • Kendt hypersensibilitet til IVIG • Hyperprolinæmia • Gravid eller ammende
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E.5 End points |
E.5.1 | Primary end point(s) |
Physical Component Summary Score (PCS) of Short Form-36 (SF-36) |
Physical Component Summary Score (PCS) fra Short Form-36 (SF-36) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Six months after randomisation |
Seks måneder efter randomisering |
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E.5.2 | Secondary end point(s) |
Mortality at 28, 90 and 180 days Time to resolution of shock Severe bleeding as clinical bleeding and use of 3 units of RBCs within 24 hours at any time in the ICU Any bleeding in the ICU Use of blood products (total volumes during the ICU admission) SOFA scores days 1-7 (AUC), excluding the GCS score Use of RRT, ventilation and vasopressor in the ICU Days alive off life support in the 90 days after randomisation Days alive and out of hospital in the 180 day follow-up period Amputation, any location, within 180 days SARs in the ICU (allergic reactions, haemolytic anaemia, aseptic meningitis syndrome, thrombi, transmittable agents and acute kidney injury as noted in the SPC for Privigen)
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Mortalitet efter 28, 90 og 180 dage Tid til patienten ikke længere er i shock Svær blødning sv.t. klinisk blødning og brug af 3 enheder RBC inden for 24 timer på ITA Enhver blødning på ITA Forbrug af blodprodukter (toal volumen under ITA indlæggelse) SOFA scores dag 1-7 (AUC), uden GCS Brug af dialyse, ventilation og vasopressor på ITA Dage i live og uden "life support" i 90 dage efter randomisering Dage i live og uden for hospital i opfølgningsperioden (180 dage) Amputationsgrad, enhver lokalisation, indenfor 180 dage SARs på ITA (allergiske reaktioner, hæmolytisk anæmi, aseptisk meningitis syndrom, thrombi, overførbare agens og akut nyresvigt, som beskrevet i SPC for Privigen)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
28, 90 and 180 days (mortality) Varying (time to resolution of shock) In the ICU (severe bleeding as clinical bleeding and use of 3 units of RBCs within 24 hours) In the ICU (any bleeding in the ICU) In the ICU (use of blood products (total volumes during the ICU admission)) Day 1-7 (SOFA scores (AUC), excluding the GCS score) In the ICU (use of RRT, ventilation and vasopressor) Day 1-90 (days alive off life support) Day 1-180 (days alive and out of hospital) Day 1-180 (need for amputation) In the ICU (SARs)
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28, 90 og 180 dage (mortalitet) Varierende (tid til patienten ikke længere er i shock) På ITA (svær blødning sv.t. klinisk blødning og brug af 3 enheder RBC inden for 24 timer) På ITA (enhver blødning på ITA) På ITA (forbrug af blodprodukter (toal volumen under ITA indlæggelse)) Dag 1-7 (SOFA scores (AUC), uden GCS) På ITA (brug af dialyse, ventilation og vasopressor) Dag 1-90 (dage i live og uden "life support") Dag 1-180 (dage i live og uden for hospital) Dag 1-180 (amputationsgrad) På ITA (SARs) |
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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 | 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) | 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.8.2.4 | 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 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |