Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 48 of 578 for:    meningitis

Determination of Levels of Micafungin in Neonates Suffering From Systemic Candidiasis and/or Candida Meningitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03421002
Recruitment Status : Completed
First Posted : February 2, 2018
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
IRCCS, Ospedale Pediatrico Bambino Gesu
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Brief Summary:
The primary purpose of this study is to evaluate the pharmacokinetic profile of micafungin administered to neonates suffering from systemic candidiasis. This study will also evaluate the proportion of success and of failure of the therapy with micafungin among treated neonates and will identify a conversion factor to relate plasma levels of micafungin into capillary and venous blood measured through blood samples from the heel and from a peripheral vein, collected simultaneously. Safety of micafungin in neonates will also be assessed.

Condition or disease Intervention/treatment Phase
Candidiasis, Systemic Candida Meningitis Drug: Micafungin Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Determination of Plasmatic and CSF Levels of High Doses of Micafungin in Neonates Suffering From Systemic Candidiasis and/or Candida Meningitis
Actual Study Start Date : May 30, 2015
Actual Primary Completion Date : April 10, 2018
Actual Study Completion Date : April 10, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Micafungin
Micafungin will be administered a minimum of 14 days
Drug: Micafungin
Micafungin is administered through intravenous infusion of a micafungin solution for approximately 1 hour.
Other Name: Mycamine




Primary Outcome Measures :
  1. Pharmacokinetics (PK) of micafungin in blood : Concentration [ Time Frame: Predose and after 1, 2, and 8 hours postdose on one of treatment days from Day 3 to Day 10 ]
    Concentration will be determined from the PK blood samples collected via capillary micro-method (draws from the heal)

  2. Pharmacokinetics (PK) of micafungin in cerebral spinal fluid (CSF): Concentration [ Time Frame: Predose and after 1, 2, and 8 hours postdose on one of treatment days from Day 3 to Day 10 ]
    Concentration will be determined from the CSF samples collected


Secondary Outcome Measures :
  1. Percentage of the success of the therapy among treated patients with systemic candidiasis [ Time Frame: up to 16 days ]
    The success of the therapy will be determined by survival associated with the negative results to candida test of two consecutive blood cultures, performed starting from the beginning of treatment, or by resolution of clinical and laboratory symptoms together with reduction of mannan antigen blood level (<125 pg/ml).

  2. Percentage of the failure of the therapy among treated patients with systemic candidiasis [ Time Frame: up to 16 days ]
    The failure of the therapy will be determined by death due to candida sepsis, by confirmation of persistence of positive result to candida test from one blood culture performed by the need to add or switch to another antifungal agent and/or change of micafungin dosage for the resolution of infection at any time or by the persistence of Candida colonization in the different indicated sites associated with the persistence of clinical and laboratory symptoms and with high blood level of the mannan antigen (≥ 125 pg/ml).

  3. Percentage of the success of the therapy among treated patients with candida meningitis [ Time Frame: up to 16 days ]
    The success of the therapy will be determined by survival associated with the negative results to candida test of at least two consecutive CSF cultures, performed starting from the beginning of treatment, and resolution of clinical and laboratory symptoms.

  4. Percentage of the failure of the therapy among treated patients with candida meningitis [ Time Frame: up to 16 days ]
    The failure of the therapy will be determined by death due to candida meningitis, by persistence of candida infection as resulted from confirmation of positive CSF culture of therapy or by the need to add or switch to another antifungal agent or dosage change of micafungin for the resolution of candida infection at any time.

  5. Percentage of the success of the therapy among treated neonates with hydrocephalus due to candida infection and/or external ventricular derivation [ Time Frame: up to 16 days ]
    The success of the therapy will be determined by survival associated with the negative results to candida test of at least two consecutive CSF cultures, performed starting from the beginning of treatment.

  6. Percentage of the failure of the therapy among treated neonates with hydrocephalus due to candida infection and/or external ventricular derivation [ Time Frame: up to 16 days ]
    The failure of the therapy will be determined by death due to candida infection, by need to add or switch to another antifungal agent or dosage change of micafungin for the resolution of candida infection at any time or by the persistence of candida infection as resulted from confirmation of positive CSF culture.

  7. Number of adverse events [ Time Frame: Up to 46 days ]
    Adverse reactions as a measurement of safety.

  8. Number of adverse drug reactions [ Time Frame: Up to 46 days ]
    Adverse drug reactions as a measurement of safety.

  9. Pharmacokinetics (PK) of micafungin: Area under the concentration - time curve (AUC) [ Time Frame: Predose and after 1, 2 and 8 hours postdose ]
    AUC will be derived from the PK blood samples collected.

  10. Pharmacokinetics (PK) of micafungin: Clearance [ Time Frame: Predose and after 1, 2 and 8 hours postdose ]
    Clearance will be derived from the PK blood samples collected.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 180 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infection by systemic candidiasis Systemic candidiasis is diagnosed in case of worsening of clinical conditions while on therapy with antibiotics, in case of isolation of candida from at least one sample collected from a normally sterile site (Blood, CSF, Urine, Peritoneal Fluid) and/or from at least two non contiguous sites (tracheal aspirate, gastric aspirate, faeces) and/or positivity to candida through polymerase chain reaction (PCR)(Septifast test), associated with at least one clinical symptom (fever or hypothermia, mottled skin, feeding difficulties, muscular hypotonia or hypertonia, apnoea crisis, bradycardia, tachycardia, hypotension, dyspnea, polypnea, desaturation) and one laboratory symptom (white blood cell [WBC] ≤5000/mm3 or WBC ≥20.000/mm3, immature to total neutrophil ratio [I/T ratio] >2, Platelet count ≤100.000/mm3, C-reactive Protein >0,5 mg/dL, Standard Base Excess >-7 mmol/L, CSF pleocytosis-cells ≥ 6) and/or positivity to test Enzyme Linked Immuno-Sorbent Assay (ELISA) for the mannan antigen (≥125 pg/ml).
  • Neonates affected by candida meningitis and/or hydrocephalus due to candida infection and/or bearing external ventricular derivation, until enrollment of at least 4 subjects with this characteristics.
  • Parents of neonates, or legal representative, able to consent and comply with protocol requirements.
  • Survival expectation not inferior to 3 days.

Exclusion Criteria:

  • Acute hepatopathy (ammonium > 200 µg/dL) or chronic hepatopathy.
  • Known allergy or hypersensitivity to echinocandins or any of the excipients present in the formulation of the investigational product.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421002


Locations
Layout table for location information
Italy
Site IT39001
Rome, Italy, 00146
Site IT39002
Rome, Italy, 00186
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
IRCCS, Ospedale Pediatrico Bambino Gesu
Investigators
Layout table for investigator information
Study Director: Executive Medical Director Astellas Pharma Global Development, Inc.

Layout table for additonal information
Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT03421002     History of Changes
Other Study ID Numbers: 9463-CL-6001
2014-003087-20 ( EudraCT Number )
800_OPBG_2014 ( Other Identifier: Ospedale Pediatrico Bambino Gesu Clinical & Research Center )
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
candida meningitis
Mycamine
candidiasis, systemic
micafungin

Additional relevant MeSH terms:
Layout table for MeSH terms
Meningitis
Candidiasis
Central Nervous System Diseases
Nervous System Diseases
Mycoses
Micafungin
Antifungal Agents
Anti-Infective Agents