Cytomegalovirus InfectionsPhase 3NCT00004278
Phase III Randomized, Controlled Study of Ganciclovir for Symptomatic Congenital Cytomegalovirus Infection
A Phase 3 study testing ganciclovir in people with Cytomegalovirus Infections, run by National Center for Research Resources (NCRR).
Trial summary
OBJECTIVES: I. Evaluate the efficacy of ganciclovir (12 mg/kg per day) versus no treatment in neonates with symptomatic congenital cytomegalovirus infection with central nervous system disease. Read more about this study
- Who is it for?
- Ages 0 years to 1 month
- Conditions the study is for
- Cytomegalovirus Infections
- What is being tested?
- ganciclovir
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Dec 1991to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years to 1 month
- All sexes
- No healthy volunteers
- Child
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Symptomatic cytomegalovirus (CMV) infection: Central nervous system disease, with or without other organ system involvement, e.g.: Microcephaly, i.e., less than 5% for age Radiologic changes indicating brain disease Cerebrospinal fluid exam abnormal for age Chorioretinitis Hearing defects
- CMV confirmed by urine, throat, buffy coat, and/or conjunctiva culture
- No hydroencephalopathy or other devastating brain involvement
--Prior/Concurrent Therapy--
- No concurrent antiviral agent No concurrent immune globulin
--Patient Characteristics--
- Age: Under 1 month (preferably under 2 weeks)
- Life expectancy: No imminent demise
- Renal: Creatinine no greater than 1.5 mg/dL
- Other: Birth weight at least 1200 g Gestational age at least 32 weeks No HIV infection No concurrent bacterial infection Eligible if resolved following 2-week treatment and CMV symptoms persist
About this study
OBJECTIVES:
- Evaluate the efficacy of ganciclovir (12 mg/kg per day) versus no treatment in neonates with symptomatic congenital cytomegalovirus infection with central nervous system disease.
Read the detailed description
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by participating institution.
Patients are randomly assigned to no antiviral therapy or intravenous ganciclovir every 12 hours for 6 weeks.
Patients are followed at weeks 1-4 and 12, months 6, 12, 24, 36, 48, and 60, and yearly thereafter until puberty (when possible).
- Conditions
- Cytomegalovirus Infections
- Being tested
- ganciclovir
- Keywords
- congenital cytomegalovirus infection, cytomegalovirus infection, herpesvirus infection, immunologic disorders and infectious disorders, neonatal disorders, rare disease, viral infection
- Medical subject headings
- Cytomegalovirus Infections, Herpesviridae Infections, Immune System Diseases, Communicable Diseases, Infant, Newborn, Diseases, Rare Diseases, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ganciclovirDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startDec 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 130 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Investigators
- Richard J. Whitley, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004278
- Sponsor's protocol ID
- 199/11689
- Other IDs
- NIAID-558607
- Status last verified
- Jul 2000
- First submitted
- 18 Oct 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized, Controlled Study of Ganciclovir for Symptomatic Congenital Cytomegalovirus Infection
- ClinicalTrials.gov ID
- NCT00004278
- Acronym / sponsor ID
- 199/11689
- Conditions
- Cytomegalovirus Infections
- Keywords
- congenital cytomegalovirus infection, cytomegalovirus infection, herpesvirus infection, immunologic disorders and infectious disorders, neonatal disorders, rare disease, viral infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Dec 1991
- First posted
- 19 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
- Evaluate the efficacy of ganciclovir (12 mg/kg per day) versus no treatment in neonates with symptomatic congenital cytomegalovirus infection with central nervous system disease.
Detailed description
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by participating institution.
Patients are randomly assigned to no antiviral therapy or intravenous ganciclovir every 12 hours for 6 weeks.
Patients are followed at weeks 1-4 and 12, months 6, 12, 24, 36, 48, and 60, and yearly thereafter until puberty (when possible).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 0 years to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ganciclovir | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard J. Whitley study chair
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ganciclovir in people with Cytomegalovirus Infections, run by National Center for Research Resources (NCRR).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.