Clinical Trial Results:
Efficacy of IntraVenous ImmunoGlobulins in Toxic Shock Syndromes: a Paediatric Pilot Study (IVIG)
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Summary
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EudraCT number |
2013-005509-29 |
Trial protocol |
FR |
Global end of trial date |
19 Apr 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Jul 2022
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First version publication date |
02 Jul 2022
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
2013-841
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02219165 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Hospices Civils de Lyon
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Sponsor organisation address |
3 Quai des Célestins, Lyon, France, 69002
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Public contact |
Valerie Plattner, Hospices Civils de Lyon, 33 0472406840, valerie.plattner@chu-lyon.fr
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Scientific contact |
Etienne Javouhey, Hospices Civils de Lyon, 33 472 129 735, etienne.javouhey@chu-lyon.fr
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
06 May 2021
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
15 Mar 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
19 Apr 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Evaluer la faisabilité d’une étude contrôlée randomisée portant sur l’efficacité des immunoglobulines humaines normales en phase aiguë d’un choc toxique (staphylococcique ou streptococcique) en pédiatrie.
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Protection of trial subjects |
- Implementation of a DSMB
- Anesthetic patches were proposed to patients when an extra venous puncture was performed specifically for the trial
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jun 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
France: 30
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Worldwide total number of subjects |
30
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EEA total number of subjects |
30
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
3
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Children (2-11 years) |
13
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Adolescents (12-17 years) |
14
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||
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Pre-assignment
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Screening details |
Patients were assessed for eligibility upon arrival in the intensive care unit. Once the investigator has confirmed the diagnosis of toxic shock syndrome, he informed the parents (and the patient when possible) orally and in writing. Randomization was performed after their consent. | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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IVIG 2 g/kg-Albumin | ||||||||||||||||||
Arm description |
The treatment was given in a single administration. The IvIG were in vials at a concentration of 10g / 100 mL. As the dose assigned was 2 g / kg, patients had to be dispensed with 1 vial for every 5 kg of body weight. Dose charts and administration rates were made available to investigators. The initial infusion rate was 0.3 ml / kg bw / h. If well tolerated, the administration rate could be gradually increased to 4.8 ml / kg bw / h. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Privigen
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
The treatment was given in a single administration. The IvIG were in vials at a concentration of 10g / 100 mL. As the dose assigned was 2 g / kg, patients had to be dispensed with 1 vial for every 5 kg of body weight. Dose charts and administration rates were made available to investigators. The initial infusion rate was 0.3 ml / kg bw / h. If well tolerated, the administration rate could be gradually increased to 4.8 ml / kg bw / h.
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Arm title
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Vialebex® 4% | ||||||||||||||||||
Arm description |
In order to maintain the blind, administration details were the same as those of IvIG. The treatment was given in a single administration. Patients were dispensed with 1 vial for every 5 kg of body weight. The albumin was in vials at a concentration of 4 g / 100 mL, thus the dose in this arm was 0,8 g / kg. The same dose charts and administration rates were made available to investigators. The initial infusion rate was 0.3 ml / kg bw / h. If well tolerated, the administration rate could be gradually increased to 4.8 ml / kg bw / h. | ||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||
Investigational medicinal product name |
Vialebex
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Dosage and administration details (frequency of dosing, formulation details, etc) : In order to maintain the blind, administration details were the same as those of IvIG. The treatment was given in a single administration. Patients were dispensed with 1 vial for every 5 kg of body weight. The albumin was in vials at a concentration of 4 g / 100 mL, thus the dose in this arm was 0,8 g / kg. The same dose charts and administration rates were made available to investigators. The initial infusion rate was 0.3 ml / kg bw / h. If well tolerated, the administration rate could be gradually increased to 4.8 ml / kg bw / h.
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
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Subject analysis sets
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Subject analysis set title |
Full Analysis Set
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All the patients who signed the informed consent.
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End points reporting groups
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Reporting group title |
IVIG 2 g/kg-Albumin
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Reporting group description |
The treatment was given in a single administration. The IvIG were in vials at a concentration of 10g / 100 mL. As the dose assigned was 2 g / kg, patients had to be dispensed with 1 vial for every 5 kg of body weight. Dose charts and administration rates were made available to investigators. The initial infusion rate was 0.3 ml / kg bw / h. If well tolerated, the administration rate could be gradually increased to 4.8 ml / kg bw / h. | ||
Reporting group title |
Vialebex® 4%
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Reporting group description |
In order to maintain the blind, administration details were the same as those of IvIG. The treatment was given in a single administration. Patients were dispensed with 1 vial for every 5 kg of body weight. The albumin was in vials at a concentration of 4 g / 100 mL, thus the dose in this arm was 0,8 g / kg. The same dose charts and administration rates were made available to investigators. The initial infusion rate was 0.3 ml / kg bw / h. If well tolerated, the administration rate could be gradually increased to 4.8 ml / kg bw / h. | ||
Subject analysis set title |
Full Analysis Set
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All the patients who signed the informed consent.
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End point title |
Feasibility [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Day 1
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There is no statistical test in this study as it's only a descriptive analysis |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Protocol deviations rate [2] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
PICU discharge
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There is no statistical test in this study as it's only a descriptive analysis |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Missing data rate [3] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
month 12
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There is no statistical test in this study as it's only a descriptive analysis |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
At day 1, day 2, day 3, day 4, day 5, PICU discharge, day 60, month 12
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
NA
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Reporting groups
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Reporting group title |
Total
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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18 Dec 2015 |
- 12-month increase in the length of recruitment
- Details provided in the protocol (dose of treatment administered to patients whose BMI for age is <3 ° percentile or> 97 ° percentile; nature of the data collected between Day 2 and Day 5 ; nature of the deviations from the protocol that will be used in the decision-making process concerning the implementation of the efficacy study; statistical analyses to be performed at the end of the trial)
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25 Apr 2016 |
- Kawasaki disease added as a non-inclusion criterion
- Adaptation of fluid bolus volume required for inclusion to the age of patients
- Precision regarding the definition of patients mistakenly included (for staphylococcal shocks)
- The sentences on how and when to administer study treatment have been reworded
- Addition of a visit at Month 12
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
