Pleconaril Enteroviral Sepsis Syndrome

NCT00031512 | Completed Phase 2 FDA Drug

• 1 other identifier: 99-018
• Study Type: interventional
• Target: 61
• Locations: 2 countries
• Sites: 25

Brief Summary

A common group of viruses that infect humans are enteroviruses. Enteroviruses produce illnesses in children which may range from very mild (summer colds) to severe (infections of the brain, liver, and heart). The purpose of this study is to determine if a new drug called pleconaril helps treat babies with enteroviral sepsis. In addition, researchers are attempting to determine a safe and effective dose of pleconaril to help babies with this disease. Infants who are 15 days or younger when diagnosed with enteroviral disease are eligible for this study. Two out of 3 babies will be randomly assigned to receive Pleconaril and the other one out of three will receive a placebo (inactive substitute). Participants will be hospitalized while receiving study medication. Babies will receive standard treatment care for their symptoms and will be observed for their medical progress. Participants may be in the study for up to 2 years.

Conditions

Enterovirus Infection

Keywords

enteroviral sepsis; enterovirus; infants; Pleconaril

Outcome Measures

Primary Outcomes (1)

• Percentage of patients shedding virus (as detected by viral culture) from the oropharynx (i.e. throat).

  5 days after beginning study drug.

Secondary Outcomes (8)

• Change in baseline laboratory abnormalities [aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, platelets, creatinine), reflecting either resolution or progression of enteroviral disease.

  Day 1 (at study enrollment), 3, 5, 7, 10 and 14.

• Duration (in days) of shedding of virus (as detected by viral culture) from the rectum, oropharynx (i.e. throat), urine and serum.

  Day 1 (immediately prior to first dose of study drug), Days 2, 3, 4, 5, 7, 10 and 14.

• Duration (in days) of total hospitalization.

  At discharge from hospital.

• Pleconaril pharmacokinetics.

  Days 1, 3 and 7.

• Safety.

  After each clinical and safety evaluation during the treatment and follow-up period (through Day 180 +/- 14 days).

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo.

Other: Placebo

Pleconaril (VP63843)

EXPERIMENTAL

The first dosing cohort received 5 mg/kg/dose oral every 8 hours for 7 days (21 doses) of a 40 mg/mL oral liquid formulation. Subsequent dosing cohorts are receiving 8.5 mg/kg/dose oral every 8 hours for 7 days (21 doses) of a 40 mg/mL oral suspension formulation.

Drug: Pleconaril

Interventions

Placebo OTHER

Placebo.

Placebo

Pleconaril DRUG

5 mg/kg /dose oral every 8 hours for 7 days (21 doses) of a 40 mg/mL oral liquid formulation and 8.5 mg/kg/dose oral every 8 hours for 7 days (21 doses) of a 40 mg/mL oral suspension formulation.

Pleconaril (VP63843)

Eligibility Criteria

• Age: 0 Days - 15 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Signed informed consent statement by parent or legal guardian. -Age less than or equal to 15 days at time of onset of disease symptoms. Symptoms of systemic illness include but are not limited to fever, irritability, poor feeding, emesis, or diarrhea. Signs of systemic illness include, but are not limited to, jaundice, seizures, or lethargy. -Onset of disease symptoms less than or equal to 10 days (240 hours) prior to administration of first dose of study medication. -Birth weight greater than or equal to 1500 grams. -Gestational age of greater than or equal to 32 weeks. -Suspected or proven enteroviral disease. -One or more of the following three conditions: a. serum glutamic pyruvic transaminase (SGPT) greater than 3 times the upper limit of normal (ULN); b. platelet count less than 100,000 and prothrombin time greater than 1.5 times ULN and positive fibrin split products; c. cardiac shortening fraction less than 25% or cardiac ejection fraction less than 50% as measured by echocardiography.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (25)

Children's of Alabama Child Health Research Unit (CHRU)

Birmingham, Alabama, 35233-0011, United States

Location

University of Arkansas - Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202-3500, United States

Location

Ronald Reagan University of California Los Angeles Medical Center

Los Angeles, California, 90095-8358, United States

Location

Rady Children's Hospital San Diego

San Diego, California, 92123-4223, United States

Location

Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases

Stanford, California, 94305-2200, United States

Location

Children's Hospital Colorado - Infectious Disease

Aurora, Colorado, 80045-7106, United States

Location

University of Florida - Shands Children's Hospital

Gainesville, Florida, 32610-0296, United States

Location

The University of Chicago - Comer Children's Hospital - Infectious Diseases

Chicago, Illinois, 60637-1425, United States

Location

University of Louisville School of Medicine - Norton Children's Hospital - Infectious Diseases

Louisville, Kentucky, 40202-1821, United States

Location

Tulane University - Tulane Medical Center - Pediatrics

New Orleans, Louisiana, 70112-2600, United States

Location

University of Mississippi - Children's Infectious Diseases

Jackson, Mississippi, 39216-4505, United States

Location

Washington University School of Medicine in St. Louis - Center for Clinical Studies

St Louis, Missouri, 63110-1010, United States

Location

University of Nebraska Medical Center - Children's Hospital and Medical Center - Infectious Diseases

Omaha, Nebraska, 68114-4108, United States

Location

Childrens Hospital at Saint Peters University Hospital - Allergy, Immunology and Infectious Diseases

New Brunswick, New Jersey, 08901-1766, United States

Location

SUNY Upstate Medical University Hospital - Pediatrics

Syracuse, New York, 13210-2342, United States

Location

Nationwide Children's Hospital - Infectious Diseases

Columbus, Ohio, 43205-2664, United States

Location

Children's Hospital of Pittsburgh of UPMC - Allergy, Immunology and Infectious Diseases

Pittsburgh, Pennsylvania, 15213-3320, United States

Location

Rhode Island Hospital - Pediatrics

Providence, Rhode Island, 02903-4923, United States

Location

Vanderbilt University - Pediatric - Infectious Diseases

Nashville, Tennessee, 37232-0011, United States

Location

Parkland Memorial Hospital

Dallas, Texas, 75235-7708, United States

Location

University of Texas Southwestern Medical Center - Pediatrics

Dallas, Texas, 75390-9063, United States

Location

Cook Children's Infectious Disease Services

Fort Worth, Texas, 76104-2710, United States

Location

University of Texas Medical Branch - Pediatrics - Infectious Diseases and Immunology - Galveston

Galveston, Texas, 77555-5302, United States

Location

University of Texas Health Science Center San Antonio - Pediatrics - Immunology & Infectious Disease

San Antonio, Texas, 78229-3901, United States

Location

University of Alberta Hospital - Pediatrics

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Enterovirus Infections

Interventions

pleconaril

Condition Hierarchy (Ancestors)

Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2002
• First Posted: March 7, 2002
• Study Start: June 27, 2001
• Primary Completion: September 22, 2010
• Study Completion: September 15, 2012
• Last Updated: February 5, 2024

Record last verified: 2012-08-09

Locations

US (24); CA (1)