E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Blood stream infections in neonates |
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E.1.1.1 | Medical condition in easily understood language |
Infections in the blood in newborn infants |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
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 determine whether the use of 2% chlorhexidine in 70% isopropyl alcohol compared to 10% povidone-iodine for skin antisepsis prior to central venous catheter insertion results in fewer catheter related blood stream infections in infants<31 weeks gestation |
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E.2.2 | Secondary objectives of the trial |
To determine whether using chlorhexidine compared to povidone-iodine for skin antisepsis before central line insertion in preterm infants is associated with beneficial effects (e.g. shorter hospital stay) or negative effects (e.g. increased skin reactions). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion Criteria Only infants who meet all of the following inclusion criteria will be eligible for enrolment into this study: 1. Born at < 31 weeks gestation (by best obstetric estimate) 2. Have a central venous catheter inserted (UVC or PICC) in the neonatal intensive care unit (NICU) of one of the participating centres. 3. Who’s parent/legal guardian are willing and able to understand and provide written, informed consent prior to their Infant’s participation in the study.
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E.4 | Principal exclusion criteria |
Infants meeting any of the following exclusion criteria are not eligible for enrolment into this study:
1. Infants with major congenital anomalies, including but not limited to gastroschisis, diaphragmatic hernia, oesophageal atresia, omphalocoele; tracheo-oesophageal fistula; neural tube defect; structural heart lesion other than patent ductus arteriosus or small atrial or ventricular septal defect. 2. Infants who have previously had a CVC placed at a participating or referring hospital. 3. Infants who are participating in another clinical trial involving an investigational medicinal product.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Endpoint The primary endpoint for this study is the number of infants with a Catheter Related Blood Stream Infections (CR-BSI). Infants will be diagnosed with a CR-BSI if they have:
1. CVC (UVC or PICC) in situ or removed within previous 48 hours AND o a recognized pathogen (e.g staphylococcus aureus, candida) on 1 peripheral blood culture (i.e. not taken through CVC) not related to an infection at another site OR o a common skin commensal (e.g. CONS) cultured from 2 or more peripheral blood cultures drawn on separate occasions OR o a common skin commensal (e.g. CONS) isolated from 1 peripheral blood culture with a CVC tip culture growing > 15 colonies of a pure growth of the same
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The decision to perform a blood culture will be at the discretion of the treating clinicians. The primary outcome will be determined by one Investigator from blood culture results and CVC tip culture results. This Investigator will be masked to the infant’s treatment allocation. |
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E.5.2 | Secondary end point(s) |
The secondary endpoints for this study are assessment of the following parameters in relation to catheter related blood stream infections: o Number of CVC insertions, attempted and successful o Duration CVC in situ (days) o Number of blood cultures taken o Episodes of positive blood culture and ≥ 5 days of antibiotics o Number of courses of antibiotics o Duration of antibiotic therapy (days) o Skin reactions to cleansing solutions o Number of CSF confirmed infections o Pericardial effusions o Pleural effusions o Bacterial endocarditis o Raised thyroid stimulating hormone levels on newborn screening (Guthrie) card o Duration of mechanical ventilation (days) o Duration of CPAP (days) o Duration of oxygen therapy (days) o Oxygen therapy at 28 days of age o Oxygen therapy 36 weeks’ post-menstrual age o Home oxygen therapy required upon discharge o Air leaks o Medical and surgical treatment for patent ductus arteriosus o Duration receiving parenteral nutrition (days) o Time to 120mL/kg/day enteral feeds o Gastrointestinal perforation o Necrotising enterocolitis o Cranial ultrasound abnormalities (intraventricular hemorrhage and periventricular leukomalacia) o Retinopathy of prematurity o Duration of hospital stay (days) o Death before discharge
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
These secondary endpoints will be assessed from time of insertion of first CVC until death or discharge. |
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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) | 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 | 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) | 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
| 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 | 6 |
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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The end of the trial is defined as 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 | 4 |
E.8.9.1 | In the Member State concerned days | 0 |