|
Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth Clinical research trials and Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth. Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth clinical trial. Human subjects often receive the most effective healthcare possible for their Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "O" Clinical Trials Conditions > Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth  Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth
Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth
For Condition: Herpes Simplex
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to test whether long-term treatment with oral acyclovir improves the outcome for infants with HSV disease of the skin, eyes, and mouth (SEM disease).
Details: HSV complicates 1 out of every 3,000 births in the United States. This study focuses on infants with HSV infection isolated to the skin, eyes and mouth (SEM disease). Medication (acyclovir) given through a vein (IV) helps to treat SEM lesions. However, in about half the babies with SEM disease, HSV will come back after IV acyclovir treatment is stopped. HSV may come back in the central nervous system, the SEM or other body organs, causing serious complications. Long-term (6 months) treatment with oral acyclovir following IV acyclovir may reduce the reappearance of HSV disease. In this study, infants initially receive the standard treatment for SEM disease: IV acyclovir for 14 days. Eligible patients are randomized to receive a syrup that contains either acyclovir or placebo (contains no medicine) by mouth for 6 months. Patients are followed for any recurrences of HSV lesions and will receive medical treatment for such lesions. Patients will return to the clinic for follow-up evaluations once a year for 5 years after study treatment is completed.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Placebo Control, Parallel Assignment
Minimum Age/Maximum Age: /24 Months
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: - Was 28 days of age or less when SEM disease was first diagnosed. - Weighed at least 800 grams at birth. - Has documented HSV that has not spread to the central nervous system or other organs of the body. EXCLUSION CRITERIA: - Has had bleeding in the brain prior to the study entry. - Has HSV infection in the central nervous system or other body organs. - Has poorly functioning kidneys (creatinine greater than 1.5 mg/dL) at time of study enrollment. - Was born to a woman known to be HIV positive. - Is being breast-fed and the mother is taking acyclovir, valacyclovir, or famciclovir for more than 120 hours (more than 5 days) or if the infant is receiving acyclovir expectantly.
Total Enrollment: 66
Location and Contact Information:
Medical University of South Carolina *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting
University of Mississippi *Recruiting*
Jackson, Mississippi, 39216
United States
Recruiting
University of Arkansas *Recruiting*
Little Rock, Arkansas, 72201
United States
Recruiting
University of Texas Health Science Ctr - San Antonio *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting
Stanford University *Recruiting*
Stanford, California, 94305
United States
Recruiting
University of Alberta *Recruiting*
Edmonton, Alberta, T6G2B7
Canada
Recruiting
Cedars-Sinai Medical Center - Los Angeles *Recruiting*
Los Angeles, California, 90048
United States
Recruiting
Southwestern Medical Center *Recruiting*
Dallas, Texas, 75235
United States
Recruiting
Cook - Fort Worth Children's Medical Center *Recruiting*
Ft. Worth, Texas, 76104
United States
Recruiting
Carolinas Medical Center *Recruiting*
Charlotte, North Carolina, 28204
United States
Recruiting
University of Tennessee *Recruiting*
Knoxville, Tennessee, 37920
United States
Recruiting
University of Florida HSC - Jacksonville *Recruiting*
Jacksonville, Florida, 32209
United States
Recruiting
Children's Hospital of Michigan *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting
Children's Hospital & Health Center - San Diego *Recruiting*
San Diego, California, 92123
United States
Recruiting
MetroHealth Medical Center of Cleveland *Recruiting*
Cleveland, Ohio, 44109
United States
Recruiting
Mount Sinai Medical Center *Recruiting*
New York City, New York, 10029
United States
Recruiting
Rhode Island Hospital *Recruiting*
Providence, Rhode Island, 02903
United States
Recruiting
Children's Hospital Medical Center of Seattle *Recruiting*
Seattle, Washington, 98105
United States
Recruiting
Cincinnati Children's Hospital Med Ctr *Recruiting*
Cincinnati, Ohio, 45229
United States
Recruiting
Oregon Health & Science University *Recruiting*
Portland, Oregon, 97207
United States
Recruiting
Maine Medical Center *Recruiting*
Portland, Maine, 04101
United States
Recruiting
University of Texas Southwestern Medical Center *Recruiting*
Dallas, Texas, 75235
United States
Recruiting
Tulane University Medical Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting
Ohio State University *Recruiting*
Columbus, Ohio, 43210
United States
Recruiting
Johns Hopkins University - Baltimore MD (DIR/IM) *Recruiting*
Baltimore, Maryland, 21205
United States
Recruiting
Washington University *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting
University of Alabama at Birmingham *Recruiting*
Birmingham, Alabama, 35294
United States
Recruiting
University of Louisville *Recruiting*
Louisville, Kentucky, 40202-3830
United States
Recruiting
Vanderbilt University Medical Center *Recruiting*
Nashville, Tennessee, 37232
United States
Recruiting
University of Chicago *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting
SUNY Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting
Additional Information:
Study ID Numbers: 97-006;
Study Start Date: August 1997
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031447
Other Herpes Simplex Studies:
1. Phase I/II Study of High-Dose Acyclovir for Central Nervous System or Disseminated Neonatal Herpes Simplex Virus Infection
2. The Effect of Acyclovir Treatment of the Herpes Simplex Virus (HSV) Infection on HIV Levels in the Blood
3. Valaciclovir to Prevent Transmission of Herpes Simplex Virus
4. The Tolerance of HIV-Infected Patients with Herpes Group Virus Infections to Oral Doses of FIAU
5. Assessment of oral acyclovir in neonates with HSV involving the CNS
Related Studies:
Other Herpes Simplex Clinical Trials
Other Texas Clinical Trials
Other Dallas Clinical Trials
Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth
|
|
|
|
|
|
|
|
