E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Central venous catheter-related sepsis in premature neonates |
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E.1.1.1 | Medical condition in easily understood language |
Infection in the blood of babies associated with indwelling central venous lines |
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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 | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053212 |
E.1.2 | Term | Catheter sepsis |
E.1.2 | System Organ Class | 100000004862 |
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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 |
This is a small feasibility study of a group of babies whose skin will get cleaned with either aqueous- or alcohol-based formulations of 2% chlorhexidine antiseptic at the time of percutaneous central venous catheter (PCVC) insertion. Both the active ingredients in these antiseptics are presently very widely used, either alone or in combination, for skin disinfection in neonates in the UK, Europe, and North America. The primary objective is to obtain an estimate of what proportion of babies treated with the alcoholic version (2% chlorhexidine in 70% isopropyl alcohol) have PCVCs that are colonised with bacteria at the time that their catheters are removed. This will directly inform the sample size calculation for a future large-scale trial. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are: I. To gauge parents' and clinicians' willingness for babies to be randomised to 2%CHG or 70%IPA/2%CHG skin antisepsis and to determine views on factors that may affect recruitment II. To determine whether taking a skin swab after skin disinfection at catheter removal needs to be incorporated into the future large-scale trial. III. To examine whether culture of paired rather than single segments of removed catheters should be incorporated into the future large-scale trial, to increase the sensitivity of detection of catheter colonisation. IV. To determine whether molecular typing of skin and catheter isolates to a species level will be essential for the future large-scale trial. V. To estimate numbers of enrolled infants who have definite catheter-related sepsis VI. To estimate numbers of enrolled infants who have catheter-associated sepsis VII. To determine suitability and completeness of data collection methods. VIII. To describe any skin m |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Preterm infants born at <34 weeks' gestation • Requiring routine insertion of a PCVC for parenteral nutrition • No new suspected sepsis with commencement of antibiotics occurring within the 48 hours preceding planned catheter insertion • No other indwelling PCVC already in situ
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E.4 | Principal exclusion criteria |
• No realistic prospect of survival in the short term • Life-threatening congenital abnormality • Already has another indwelling PCVC in situ or was previously enrolled into the study in respect of an earlier PCVC episode • Positive blood culture within the past 7 days without a subsequent negative BC result • Antibiotic treatment commenced for suspected sepsis within the preceding 48 hours |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of babies in the 70%IPA/2%CHG arm with catheter colonisation as determined by positive bacterial culture from one or both of the catheter segments taken at catheter removal. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The timepoint at which the baby's percutaneous central venous catheter is removed. |
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E.5.2 | Secondary end point(s) |
Efficacy measures: I. Rates of recruitment and retention to the study, and the collection of views of parents and clinicians on factors affecting recruitment and retention. II. Proportion of infants with positive exit-site skin swabs (ESSS) at catheter removal III. Number and type of catheter segments culture positive at removal IV. Bacterial species (typed via molecular methods) of isolates identified on positive BC, ESSS, and catheter segment V. Proportion of infants undergoing an infection screen in the period between catheter insertion and 48 hours post catheter removal who meet case definition for definite catheter-related sepsis VI. Proportion of infants with positive blood culture from any infection screen in the period between catheter insertion and 48 hours post catheter removal who meet definition for catheter-associated sepsis VII. Proportion of infants completing study with complete data for the primary outcome and proportions of infants with missing data collection forms
Safety measure: VIII. Daily skin morbidity scores in the period between catheter insertion and 48 hours post catheter removal.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
All secondary outcome measures will be evaluated in full at the End of study
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
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 | Information not present in EudraCT |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 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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The end of trial for an individual infant is defined as being on completion of their skin and sepsis assessment done at 48 hours post catheter removal. The End of Trial overall will be defined as the time of final database lock. An End of Trial Declaration will be made to the Medicines and Healthcare products Regulatory Agency (MHRA) and to the approving REC within 3 months of this date. |
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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 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
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 |