A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children

Browse trials for

• Aspergillosis 201

Keywords

• Pediatrics voriconazole invasive fungal infection invasive aspergillosis immunocompromized

Aspergillosis

201 studies on the registry are indexed under Aspergillosis; 22 are open to participants now.

This study's enrollment of 31 is below the median of 50 across 106 interventional studies indexed under Aspergillosis.

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Study arms

• Experimental
  1

  Children from 2 to 17 years who have possible, probable or proven invasive aspergillosis, or other rare mold infection (eg, Scedosporium and Fusarium).

  Drug: Voriconazole

Interventions

• DrugVoriconazole

  All subjects will receive voriconazole for a minimum of 6 weeks and a maximum of 12 weeks. All subjects must receive intravenous (IV) voriconazole for the first week of therapy. Group 1: Subjects 2 to 11 years old and subjects 12 to 14 years old with low body weight (\<50 kg) will receive 9 mg/kg IV every 12 hours (q12h) on day 1, then 8 mg/kg IV q12h starting day 2. If there is a significant clinical improvement after the first week of IV therapy, subjects may be switched to the step-down oral regimen (9 mg/kg PO q12h with a maximum dose of 350 mg PO q12h) at the discretion of the investigator. Group 2: Subjects 12 to 17 years old (excluding 12-14-year-olds weighing \<50 kg) will receive 6 mg/kg IV q12h on day 1, then 4 mg/kg IV q12h starting day 2. Similar to Group 1, subjects may be switched to the step-down oral regimen (200 mg PO q12h) at the discretion of the investigator. Oral voriconazole can be administered as tablet or oral suspension.

Primary outcomes

1. Number of Participants With Adverse Events (AEs)

   Time frame: Baseline, daily while hospitalized, Days 7, 14, 28, 42, 84, and 114, at end of treatment, and up to 1 month post treatment

Secondary outcomes

1. Percentage of Participants With a Global Response of Success

   Percentage of participants with global response of success at Weeks 6 and at EOT (up to Week 12). Global response of success was defined as a participant who achieved a complete or partial global response per the investigator. Complete response was defined as resolution of all clinical signs and symptoms PLUS resolution of 90 percent (%) or more of the lesions visible on radiological studies and attributed to invasive aspergillosis (IA) at Baseline. Partial response was defined as clinical improvement PLUS 50% to \<90% resolution of the radiological lesions attributed to IA at Baseline.

   Time frame: Weeks 6 and End of Treatment (EOT; up to Week 12)

2. All-Cause Mortality - Number of Participant Deaths

   Number of participant deaths reported at Week 6 and at EOT (up to Week 12).

   Time frame: Week 6 and EOT (up to Week 12)

3. Attributable Mortality - Number of Participant Deaths

   Number of participant deaths attributable to study drug reported at Week 6 and at EOT (up to Week 12).

   Time frame: Weeks 6 and EOT (up to Week 12)

4. Time to Death

   Time frame: Baseline up to 1 month post treatment

Baseline characteristics

Publications

• Martin JM, Macias-Parra M, Mudry P, Conte U, Yan JL, Liu P, Capparella MR, Aram JA. Safety, Efficacy, and Exposure-Response of Voriconazole in Pediatric Patients With Invasive Aspergillosis, Invasive Candidiasis or Esophageal Candidiasis. Pediatr Infect Dis J. 2017 Jan;36(1):e1-e13. doi: 10.1097/INF.0000000000001339. PubMed 27636722 ↗

Related links

• To obtain contact information for a study center near you, click here. ↗