Pleconaril Enteroviral Sepsis Syndrome

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Pleconaril

Criteria

Inclusion Criteria:

• 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:

1. serum glutamic pyruvic transaminase (SGPT) greater than 3 times the upper limit of normal (ULN);

2. platelet count less than 100,000 and prothrombin time greater than 1.5 times ULN and positive fibrin split products;

3. cardiac shortening fraction less than 25% or cardiac ejection fraction less than 50% as measured by echocardiography.

Exclusion Criteria:

• Diagnosis of bacterial or non-enterovirus viral pathogen that can produce the constellation of presenting symptoms, known at the time of study enrollment.

• Imminent demise (estimated life expectancy less than 24 hours).

• Cyanotic congenital heart lesion.

• Alimentary tract abnormalities which may interfere with the absorption of the study drug. These include mechanical obstruction of the gastrointestinal tract, necrotizing enterocolitis, and severe ileus (the definition of which is left to the clinical judgment of the participating investigator).

• Infants known to be born to women who are human immunodeficiency virus (HIV) positive (but HIV testing is not required for study entry). These infants are at known risk of acquiring HIV, which would alter their immune response to other infections, including enteroviral infections. Additionally, they may be receiving antiretroviral and/or antiviral drugs during the time in which the study of pleconaril is being conducted. As such, they will be excluded if the mother's positive HIV status is known at the time of evaluation for study inclusion. If at any point following enrollment it is learned that an infant is HIV positive, however, he/she will be continued on the study protocol.