PER-023-16Suspended未知
A RANDOMIZED TRIAL OF COMBINED ALBENDAZOLE PLUS PRAZIQUANTEL FOR SUBARACHNOID CYSTICERCOSISOF THE SYLVIAN FISSURE OR THE BASAL CISTERNS
IVERSIDAD PERUANA CAYETANO HEREDIA,0 sites107 target enrollmentStarted: August 2, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Suspended
- Sponsor
- Enrollment
- 107
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Male or female adult individuals (18 to 65 y.o.) with a diagnosis of basal subarachnoid cysticercosis (including locations in the Sylvian fissure or lower interhemispheric spaces) by neuroimaging and confirmed by serology.
- •- Baseline laboratory results along acceptable ranges (specifically defined in the study protocol).
- •- Willingness to accomplish the two-week minimum hospitalization required.
- •Patients will be considered eligible for the study if they have NCC involving the basal cisterns, the interhemispheric brain space, or the Sylvian fissure on baseline CT or MRI. Patients with only small subarachnoid lesions (<20mm in diameter) in the convexity of the brain hemispheres will not be included because these lesions commonly respond well to therapy and behave as intraparenchymal lesions.
Exclusion Criteria
- •- Previous therapy with ABZ or PZQ in the preceding 3 years (except for patients who received single-dose ABZ for intestinal parasites, or patients who received antiparasitic treatment between one and three years before enrollment but demonstrated lesion persistence or progression during the past 12 months).
- •- A type of NCC which can expose the patient to increased risk during the study, specifically: a) intraventricular cysts; b) cysts in brainstem; c) concomitant intraparenchymal lesions greater than 3 cm of diameter in addition to their SANCC lesions; d) more than 20 intraparenchymal cysts in addition to their SANCC lesions; or d) untreated ocular cysticercosis. Patients with a lateral ventricle cyst, less than 2 cm in diameter, without hydrocephalus or intracranial hypertension, can be included. The presence of concomitant intraparenchymal cysts of less than 3 cm in diameter will not exclude the patient unless there are more than 20 of them.
- •- Active pulmonary tuberculosis evidenced by positive chest X-ray and positive sputum smears, or symptoms compatible with tuberculosis (fever+sweats or fever+cough) not otherwise explained.
- •- Individuals with positive markers for active hepatitis.
- •- Systemic disease that may affect therapy or short-term prognosis, including but not limited to chronic renal failure, hepatic insufficiency, cardiac failure, and steroid-dependent immune diseases.
- •- Patients in unstable condition or with symptomatic intracranial hypertension (ICH). Definition of symptomatic ICH for this study is the presence of headaches, nausea, and vomiting, with papilledema at fundoscopic examination. Patients in this category can be considered for entrance into the study only after resolution of ICH by ventricular-peritoneal shunting or neuroendoscopic procedures involving CSF flow derivation.
- •- Pregnancy during anti-parasitic treatment. If a patient becomes pregnant after treatment, she will continue in the study but will have radiological exams delayed until after delivery.
- •- History of hypersensitivity to ABZ or PZQ
- •- Chronic alcohol or drug abuse as defined in the study protocol.
- •- Unwilling or unable to undergo MRI exams (like patients with ferromagnetic implants)
- •- Inability or unwillingness of subject or legal representative to give written informed consent.
Investigators
Similar Trials
Not yet recruiting
Not Applicable
A RANDOMIZED TRIAL OF COMBINED ALBENDAZOLE PLUS PRAZIQUANTEL FOR SUBARACHNOID CYSTICERCOSISOF THE SYLVIAN FISSURE OR THE BASAL CISTERNSPER-001-16IVERSIDAD PERUANA CAYETANO HEREDIA,
Completed
Phase 2
A clinical study to see the effect of some Ayurvedic formulation in the treatment of far sightedness.CTRI/2021/12/038889Sane Guruji Arogya Kendra56
Active, not recruiting
Not Applicable
RANDOMIZED TRIAL OF PRASUGREL PLUS BIVALIRUDIN VERSUS CLOPIDOGREL PLUS HEPARIN IN PATIENTS WITH ACUTE STEMI BAVARIAN REPERFUSION ALTERNATIVES EVALUATION [BRAVE-4] TRIAL - BRAVE-4Acute myocardial infarctionEUCTR2009-014343-36-DEDeutsches Herzzentrum1,240
Active, not recruiting
Phase 1
Randomised double-blind trial of combination antibiotic therapy in rheumatoid arthritisPatients with medical diagnosis of Rheumatoid ArthritisEUCTR2004-004893-96-GBHammersmith Hospitals NHS trust50
Not yet recruiting
Phase 2
Randomized Clinical Trial To Evaluate The Combined Effect Of warm poultice With Heating Pad In osteoarthritis of kneeCTRI/2019/08/020989sukumaran n