Treatment With Tamoxifen in Cryptococcal Meningitis (NCT03112031) | Clinical Trial Compass
CompletedPhase 2
Treatment With Tamoxifen in Cryptococcal Meningitis
Vietnam50 participantsStarted 2017-10-10
Plain-language summary
The purpose of this study is to develop initial efficacy, feasibility, and safety data regarding the use of Tamoxifen in combination with amphotericin B and fluconazole in the treatment of cryptococcal meningitis. The results of the study will inform the design and feasibility of a larger study powered to a survival endpoint. The study hypothesis is that adding tamoxifen to standard antifungal therapy increases the rate of clearance of yeast from cerebrospinal fluid. Increased rates of clearance of yeast from cerebrospinal fluid have previously been associated with improved clinical outcomes, including survival and disability.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Cryptococcal meningitis (CM) defined as a syndrome consistent with CM and one or more of:
* positive CSF India ink (budding encapsulated yeasts),
* C. neoformans cultured from CSF or blood,
* positive cryptococcal antigen Lateral Flow Antigen Test (LFA) in CSF
* Informed consent to participate given by patient or acceptable representative
* Known HIV infection status, or patient agrees to HIV testing on this admission
Exclusion Criteria:
* Pregnancy or breast-feeding
* History of thromboembolic disease such as pulmonary embolism or deep venous thrombosis
* On anti-coagulant medication
* On medication known to prolong the QT interval other than fluconazole, such as fluoroquinolones or antidepressants.
* Known cardiac conduction defect including long QT syndromes
* QTc at baseline \> 500ms
* Currently receiving treatment for cryptococcal meningitis and having received \> 4 days of anti-cryptococcal meningitis therapy
* Known allergy to Tamoxifen
* Currently or history of receiving treatment with Tamoxifen for breast cancer or other indication
* Current or history of uterine cancer including endometrial cancer and uterine sarcoma
* Renal failure (defined as creatinine \>3\*ULN (upper limit of normal), despite adequate hydration)
* Failure to consent - the patient, or if they are incapacitated, their responsible relative, declines to enter the study
* Allergy to amphotericin B or fluconazole
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Early Fungicidal Activity (EFA), i.e. the rate of clearance of yeast from cerebrospinal fluid
Timeframe: over the first 2 weeks following randomisation
Trial details
NCT IDNCT03112031
SponsorOxford University Clinical Research Unit, Vietnam