Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004317
Status:
RECRUITING
Last Update Posted:
2009-05-14
First Post:
1999-10-18
Brief Title:
Pyrimethamine Sulfadiazine and Leucovorin in Treating Patients With Congenital Toxoplasmosis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
Phase IV Randomized Study of Pyrimethamine Sulfadiazine and Leucovorin Calcium for Congenital Toxoplasmosis
Status:
RECRUITING
Status Verified Date:
2009-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Congenital toxoplasmosis is an infection caused by the parasitic organism Toxoplasma gondii and it may be passed from an infected mother to her unborn child The mother may have mild symptoms or no symptoms the fetus however may experience damage to the eyes nervous system skin and ears The newborn may have a low birth weight enlarged liver and spleen jaundice anemia petechiae and eye damage Giving the antiparasitic drugs pyrimethamine and sulfadiazine is standard treatment for congenital toxoplasmosis but it is not yet known which regimen of pyrimethamine is most effective for the disease
PURPOSE Randomized phase IV trial to determine which regimen of pyrimethamine is most effective when combined with sulfadiazine and leucovorin in treating patients who have congenital toxoplasmosis
PURPOSE Randomized phase IV trial to determine which regimen of pyrimethamine is most effective when combined with sulfadiazine and leucovorin in treating patients who have congenital toxoplasmosis
Detailed Description:
PROTOCOL OUTLINE Infants are randomly assigned to 1 of 2 treatment groups Patients are stratified by disease severity chorioretinitis prenatal treatment and certainty of diagnosis at birth
One group of infants is treated with a loading dose of oral pyrimethamine followed by a higher dose for the first two months then a lower dose for the remainder of the 12 months Sulfadiazine and leucovorin calcium are also given orally for 12 months The pyrimethamine loading dose is omitted if prior prenatal therapy was given
Another group of infants is treated with a higher dose of oral pyrimethamine for the first 6 months and then the lower dose for the remainder of the 12 months Sulfadiazine and leucovorin calcium are administered concurrently
Infected fetuses of pregnant women are nonrandomly assigned to treatment with pyrimethamine sulfadiazine and leucovorin calcium after the first trimester Spiramycin is administered before the fetal diagnosis is made
Concurrent prednisone for active retinal inflammation or elevated cerebrospinal fluid protein is allowed
Collaborating physicians will also refer historical controls who have not been treated in the first year of life or who received one month or less therapy and are older than one year Absence of treatment in the first year of life will be due to parental preference prior inadequate follow-up by the family physicians or lack of detection or treatment of eye disease before the age of one year in otherwise asymptomatic children These historical untreated patients who enter the study when they are older than one year will be compared with treated children in the randomized study These historical patients will not be randomized Any abnormality requiring treatment eg active chorioretinitis in any child including historical patients will be treated
All infants are followed at birth then at age 1 35 5 75 10 15 and 20
One group of infants is treated with a loading dose of oral pyrimethamine followed by a higher dose for the first two months then a lower dose for the remainder of the 12 months Sulfadiazine and leucovorin calcium are also given orally for 12 months The pyrimethamine loading dose is omitted if prior prenatal therapy was given
Another group of infants is treated with a higher dose of oral pyrimethamine for the first 6 months and then the lower dose for the remainder of the 12 months Sulfadiazine and leucovorin calcium are administered concurrently
Infected fetuses of pregnant women are nonrandomly assigned to treatment with pyrimethamine sulfadiazine and leucovorin calcium after the first trimester Spiramycin is administered before the fetal diagnosis is made
Concurrent prednisone for active retinal inflammation or elevated cerebrospinal fluid protein is allowed
Collaborating physicians will also refer historical controls who have not been treated in the first year of life or who received one month or less therapy and are older than one year Absence of treatment in the first year of life will be due to parental preference prior inadequate follow-up by the family physicians or lack of detection or treatment of eye disease before the age of one year in otherwise asymptomatic children These historical untreated patients who enter the study when they are older than one year will be compared with treated children in the randomized study These historical patients will not be randomized Any abnormality requiring treatment eg active chorioretinitis in any child including historical patients will be treated
All infants are followed at birth then at age 1 35 5 75 10 15 and 20
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCRCC-08796 | None | None | None |
| UCCRC-08796 | None | None | None |
| MRH-850410 | None | None | None |