CryptosporidiosisPhase 2NCT03341767

A Phase 2A Evaluation of the Safety, Tolerability, Pharmacokinetics, Efficacy of Clofazimine (CFZ) in Cryptosporidiosis

A Phase 2 study testing Clofazimine in people with Cryptosporidiosis, run by University of Washington at 1 site in Malawi.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Cryptosporidiosis
What is being tested?: Clofazimine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 33 participants
Where: 1 siteMalawi
Study dates: 14 Dec 2017to 5 Jul 2019
Phase: Phase 2
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or Female, Aged 18-65 years old, HIV positive, Cryptosporidium positive by qPCR.
HIV infection and on stable anti-retroviral therapy treatment for at least 2 weeks
Weight >78 lbs/35.4 kg
Presents with diarrhea defined as a condition of three or more loose stools per day that has persisted for 3 days or longer
If female, either not of reproductive potential (post-menopause, or status-post surgical sterilization) or using highly effective contraception (<1% failure, e.g., intrauterine contraceptive device in place or using injectable contraception) or willing to begin highly effective contraception (probably injectable contraception) and continue for the presumed exposure period of Clofazimine (54 days after initiation of treatment)
Willing and able to provide signed written informed consent or witnessed oral consent in the case of illiteracy, prior to undertaking any trial-related procedures

Who cannot join

Any condition for which participation in the study, as judged by the investigator, could compromise the well-being of the subject or prevent, limit or confound protocol specified assessments
Fever >38.0˚C at presentation
Subjects will be screened for evidence of active tuberculosis based on sputum production, fever and chest x-ray. Those with sputum production will be tested by Acid Fast Bacilli stain of sputum smear and/or by GeneXpert testing. Those with positive sputum or chest x-ray suggestive of tuberculosis will be excluded from this study and referred for treatment.
Is critically ill, or in the judgment of the investigator has a prognosis that could lead to imminent mortality within 60 days or compromise participation in the trial or endanger the subject by entering the trial.
History of allergy or hypersensitivity to Clofazimine.
Significant cardiac arrhythmia requiring medication.

Show all 25Show fewer

Electrocardiogram exclusions based on the means from triplicate electrocardiograms performed on Day -1:
Marked prolongation of QT/QTc interval, e.g., confirmed demonstration of QTcF or QTcB interval >450 ms
Pathological Q waves (defined as >40 ms or depth >0.4 to 0.5mV);
Electrocardiogram evidence of ventricular pre-excitation
Electrocardiogram evidence of complete or incomplete left bundle branch block or right bundle branch block
Electrocardiogram evidence of second or third degree heart block
Intraventricular conduction delay with QRS duration >120 ms
Bradycardia as defined by sinus rate <50 bpm.
History of additional risk factors for Torsade de Pointes, e.g., heart failure; bradycardia with HR<50 bpm, untreated hypothyroidism, hypokalemia <3.0 mEq/L
Family history of long QT syndrome
Use of concomitant medications that markedly prolong the QT/QTc interval or are predicted to have drug-drug interactions with Clofazimine that may lead to toxicity from the partner drug including Amiodarone, Amprenavir, Atazanavir, Bedaquiline, Bepridil, Chloroquine, Chlorpromazine, Cisapride, Clarithromycin, Cyclobenzaprine, Darunavir, Delamanid, Disopyramide Dofetilide, Domperidone, Droperidol, Erythromycin, Fosamprenavir, Halofantrine, Haloperidol, Ibutilide, Indinavir, Levomethadyl, Lopinavir, Mesoridazine, Methadone, Nelfinavir, Pentamidine, Pimozide, Procainamide, Quinidine, Ritonavir, Simiprinivir, Sotalol, Sparfloxacin, Thioridazine, or Tiprinivir
Pregnant and lactating women (screening pregnancy test for females and pregnancy test at the discharge follow up visit)
Use of systemic corticosteroids or anti-cryptosporidial treatments within the 28 days preceding Day -1
Subjects with clinically significant laboratory value abnormalities at screening including but not limited to (note: exclusionary results may not be returned until after enrollment but should be confirmed by the time of the beginning of administration of study drug):
Hemoglobin <5 g/dL
Serum potassium <3.0 mEq/L
Aspartate Aminotransferase or Alanine Aminotransferase ≥3.0 x ULN
Part B:
Same Eligibility Criteria except without diarrhea and is Cryptosporidium negative by qPCR.

Trial locations and contacts

1 site in 1 country.

Malawi1 site

Malawi-Liverpool-Wellcome Trust Clinical Research Programme (MLW)
Blantyre

Other trials in Malawi

About this study

Official title: A Phase 2A, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Tolerability, Pharmacokinetics and Efficacy of Clofazimine (CFZ) in Cryptosporidiosis

This study evaluates the safety, tolerability, pharmacokinetics, and efficacy of treating Cryptosporidiosis in HIV positive patients with Clofazimine. Half of the HIV positive patients with Cryptosporidiosis enrolled will be treated with Clofazimine while the other half will be given placebo. An additional group of HIV positive patients without Cryptosporidium infection or diarrhea will be given Clofazimine to assess the differences in pharmacokinetics between HIV positive patients with and without Cryptosporidiosis and diarrhea.

Read the detailed description

Cryptosporidiosium infection and diarrhea is a life-threatening infection in children 6-18 months and in immunocompromised patients. However, Nitazoxanide, the only drug approved for treatment of Cryptosporidiosis, showed little-to-no efficacy in HIV positive patients and low efficacy in malnourished children.

Recently, Love MS et al reported that Clofazimine inhibited proliferation of both Cryptosporidium parvum and C. hominis in vitro and reduced shedding in a mouse model of acute C. parvum infection. Clofazimine has been approved for treatment of leprosy for decades and more recently for the treatment of drug-resistant Mycobacterium tuberculosis. Safety and pharmacokinetics of Clofazimine are well documented for a variety of patient populations, but not for HIV positive patients or patients with diarrhea. Thus, this clinical trial seeks to determine the efficacy of 50 or 100 mg of Clofazimine administered 3 times daily for 5 days on fecal shedding of Cryptosporidium oocysts in HIV positive patients, as well as safety, tolerability, and pharmacokinetics in this patient population.

Conditions: Cryptosporidiosis
Being tested: Clofazimine, Placebo
Keywords: HIV, Cryptosporidium, Clofazimine
Medical subject headings: Cryptosporidiosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ClofazimineDrug
Also called Lamprene
50 or 100 mg micronized Clofazimine suspended in an oil-wax base in a gelatin capsule
PlaceboDrug
Also called Placebo (for Clofazimine)
Oil-wax in gelatin capsule

Study groups in NCT03341767
Study group	Role	What they receive
Clofazimine	Experimental	Subjects >/=50 kg: Clofazimine two 50mg gelatin capsules taken orally every 8 hours for 5 days Subjects <50 kg: Clofazimine 50mg gelatin capsule taken orally every 8 hours for 5 days Receives: Drug: Clofazimine
Placebo	Placebo comparator	Placebo gelatin capsule(s) taken orally every 8 hours for 5 days. Receives: Drug: Placebo
Clofazimine, no diarrhea	Experimental	Subjects >/=50 kg: Clofazimine two 50mg gelatin capsules taken orally every 8 hours for 5 days Subjects <50 kg: Clofazimine 50mg gelatin capsule taken orally every 8 hours for 5 days Receives: Drug: Clofazimine

What is being measured

The primary outcome is the main question the study is designed to answer.

Reduction in Cryptosporidium fecal shedding following Clofazimine administration
The reduction in the (log) number of Cryptosporidium shed in stools in the first collected stool of the day over a 6-day period and compared to placebo recipients, as measured by quantitative polymerase chain reaction (qPCR) in stool samples and analyzed by a mixed effect ANCOVA analysis in subjects treated according to protocol (ATP).
Measured: 5 days
Pharmacokinetics (area under curve) of Clofazimine in HIV-infected subjects with Cryptosporidium and diarrhea versus HIV-infected subjects without Cryptosporidium infection or diarrhea
Clofazimine in plasma will be assessed via area under curve.
Measured: 5 days
Peak plasma concentration of Clofazimine in HIV-infected subjects with Cryptosporidium and diarrhea versus HIV-infected subjects without Cryptosporidium infection or diarrhea
Clofazimine in plasma will be assessed via Cmax and time to reach Cmax (Tmax).
Measured: 5 days
Pharmacokinetics (Ke) of Clofazimine in HIV-infected subjects with Cryptosporidium and diarrhea versus HIV-infected subjects without Cryptosporidium infection or diarrhea
Clofazimine in plasma will be assessed via Ke determined after the last dose on day 5.
Measured: 5 days
Stool pharmacokinetics of Clofazimine in HIV-infected subjects with Cryptosporidium and diarrhea versus HIV-infected subjects without Cryptosporidium infection or diarrhea
The total daily amount of CFZ eliminated in stool will be assessed on Study Day 2 (2nd dose day), Study Day 5 (last dose day), and Study Day 6 (concentration of CFZ in stool before discharge).
Measured: 5 days
Frequency and severity of solicited adverse events (AEs)
Frequency and severity of solicited AEs throughout study product administration
Measured: 5 days
Frequency, severity, and relationship to study product of unsolicited AEs
Frequency, severity, and relationship to study product of unsolicited AEs throughout the course of the study
Measured: 55 days
Occurrence of serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), and adverse events of special interest (AESI).
Occurrence of SAEs, SUSARs, and AESIs throughout the course of the study. AESI include: QT prolongation measured via 12-lead electrocardiogram, liver toxicity, skin discoloration and other skin related AEs/abnormalities (subjects will be evaluated for discoloration of skin of the palms and of the sclera and oral mucous membranes), GI-related AEs.
Measured: 55 days

Secondary outcomes (4)

Evaluation of time to negative ELISA signal in subjects randomized to Clofazimine versus placebo
Evaluate days required to test negative for Cryptosporidium by ELISA test in subjects randomized to Clofazimine versus placebo.
Measured: 6 days
Characterization of the reduction in the number of diarrheal episodes following administration of CFZ relative to placebo.
To characterize the reduction in the number of diarrheal episodes following administration of CFZ relative to placebo.
Measured: 6 days
Characterization of the stool volume following administration of CFZ relative to placebo.
To characterize the stool volume following administration of CFZ relative to placebo.
Measured: 6 days
Characterization of the stool consistency following administration of CFZ relative to placebo.
To characterize the stool consistency based on a defined diarrheal stool grading scale following administration of CFZ relative to placebo.
Measured: 6 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Dec 20175 Jul 2019

First posted14 Nov 2017
Study start14 Dec 2017
Primary completion1 Apr 2019
Study completion5 Jul 2019

Why it stopped: Insufficient accrual rate

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for CryptosporidiosisStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel assignment, placebo-controlled with later arm for pharmacokinetics
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03341767
Sponsor's protocol ID: CFZ-001
Other IDs: CC-ID8
Status last verified: Aug 2019
First submitted: 26 Oct 2017
Last updated: 13 Aug 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Love MS, Beasley FC, Jumani RS, Wright TM, Chatterjee AK, Huston CD, Schultz PG, McNamara CW. A high-throughput phenotypic screen identifies clofazimine as a potential treatment for cryptosporidiosis. PLoS Negl Trop Dis. 2017 Feb 3;11(2):e0005373. doi: 10.1371/journal.pntd.0005373. eCollection 2017 Feb.
PubMed 28158186
Zhang CX, Love MS, McNamara CW, Chi V, Woods AK, Joseph S, Schaefer DA, Betzer DP, Riggs MW, Iroh Tam PY, Van Voorhis WC, Arnold SLM. Pharmacokinetics and Pharmacodynamics of Clofazimine for Treatment of Cryptosporidiosis. Antimicrob Agents Chemother. 2022 Jan 18;66(1):e0156021. doi: 10.1128/AAC.01560-21. Epub 2021 Nov 8.
PubMed 34748385
Iroh Tam P, Arnold SLM, Barrett LK, Chen CR, Conrad TM, Douglas E, Gordon MA, Hebert D, Henrion M, Hermann D, Hollingsworth B, Houpt E, Jere KC, Lindblad R, Love MS, Makhaza L, McNamara CW, Nedi W, Nyirenda J, Operario DJ, Phulusa J, Quinnan GV, Sawyer LA, Thole H, Toto N, Winter A, Van Voorhis WC. Clofazimine for Treatment of Cryptosporidiosis in Human Immunodeficiency Virus Infected Adults: An Experimental Medicine, Randomized, Double-blind, Placebo-controlled Phase 2a Trial. Clin Infect Dis. 2021 Jul 15;73(2):183-191. doi: 10.1093/cid/ciaa421.
PubMed 32277809
Nachipo P, Hermann D, Quinnan G, Gordon MA, Van Voorhis WC, Iroh Tam PY. Evaluating the safety, tolerability, pharmacokinetics and efficacy of clofazimine in cryptosporidiosis (CRYPTOFAZ): study protocol for a randomized controlled trial. Trials. 2018 Aug 23;19(1):456. doi: 10.1186/s13063-018-2846-6.
PubMed 30139372

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study Testing the Efficacy, Safety, and Tolerability of EDI048 in Cryptosporidium Infection Model in Healthy Adults
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RecruitingObservational study
A Study to Characterize the Clinical Presentation and Course of Cryptosporidium in Pediatric Participants
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RecruitingPhase 2
The Effect of Echinacea (Immulant ®) in the Treatment of CRYPTOSPORIDIOSIS in Immunocompromised Children
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Active, not recruitingObservational study
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All Cryptosporidiosis trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2A, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Tolerability, Pharmacokinetics and Efficacy of Clofazimine (CFZ) in Cryptosporidiosis
ClinicalTrials.gov ID: NCT03341767
Acronym / sponsor ID: CFZ-001
Conditions: Cryptosporidiosis
Keywords: HIV, Cryptosporidium, Clofazimine
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Insufficient accrual rate
Enrolment: 33 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: Bill and Melinda Gates Foundation, The Emmes Company, LLC, Calibr, a division of Scripps Research, Liverpool School of Tropical Medicine, University of Virginia, Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Study start: 14 Dec 2017 (actual)
Primary completion: 1 Apr 2019 (actual)
Study completion: 5 Jul 2019 (actual)
First posted: 14 Nov 2017 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: Parallel assignment, placebo-controlled with later arm for pharmacokinetics

Arm	Type	Receives
Clofazimine	Experimental	Drug: ClofazimineSubjects >/=50 kg: Clofazimine two 50mg gelatin capsules taken orally every 8 hours for 5 days Subjects <50 kg: Clofazimine 50mg gelatin capsule taken orally every 8 hours for 5 days
Placebo	Placebo comparator	Drug: PlaceboPlacebo gelatin capsule(s) taken orally every 8 hours for 5 days.
Clofazimine, no diarrhea	Experimental	Drug: ClofazimineSubjects >/=50 kg: Clofazimine two 50mg gelatin capsules taken orally every 8 hours for 5 days Subjects <50 kg: Clofazimine 50mg gelatin capsule taken orally every 8 hours for 5 days

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Male or Female, Aged 18-65 years old, HIV positive, Cryptosporidium positive by qPCR.
HIV infection and on stable anti-retroviral therapy treatment for at least 2 weeks
Weight >78 lbs/35.4 kg
Presents with diarrhea defined as a condition of three or more loose stools per day that has persisted for 3 days or longer
If female, either not of reproductive potential (post-menopause, or status-post surgical sterilization) or using highly effective contraception (<1% failure, e.g., intrauterine contraceptive device in place or using injectable contraception) or willing to begin highly effective contraception (probably injectable contraception) and continue for the presumed exposure period of Clofazimine (54 days after initiation of treatment)

Key exclusion criteria (25 listed)

Any condition for which participation in the study, as judged by the investigator, could compromise the well-being of the subject or prevent, limit or confound protocol specified assessments
Fever >38.0˚C at presentation
Subjects will be screened for evidence of active tuberculosis based on sputum production, fever and chest x-ray. Those with sputum production will be tested by Acid Fast Bacilli stain of sputum smear and/or by GeneXpert testing. Those with positive sputum or chest x-ray suggestive of tuberculosis will be excluded from this study and referred for treatment.
Is critically ill, or in the judgment of the investigator has a prognosis that could lead to imminent mortality within 60 days or compromise participation in the trial or endanger the subject by entering the trial.
History of allergy or hypersensitivity to Clofazimine.

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
ClofazimineAlso: Lamprene50 or 100 mg micronized Clofazimine suspended in an oil-wax base in a gelatin capsule	Drug	Clofazimine, Clofazimine, no diarrhea
PlaceboAlso: Placebo (for Clofazimine)Oil-wax in gelatin capsule	Drug	Placebo

Primary outcome

Reduction in Cryptosporidium fecal shedding following Clofazimine administration
Time frame: 5 days
The reduction in the (log) number of Cryptosporidium shed in stools in the first collected stool of the day over a 6-day period and compared to placebo recipients, as measured by quantitative polymerase chain reaction (qPCR) in stool samples and analyzed by a mixed effect ANCOVA analysis in subjects treated according to protocol (ATP).
Pharmacokinetics (area under curve) of Clofazimine in HIV-infected subjects with Cryptosporidium and diarrhea versus HIV-infected subjects without Cryptosporidium infection or diarrhea
Time frame: 5 days
Clofazimine in plasma will be assessed via area under curve.
Peak plasma concentration of Clofazimine in HIV-infected subjects with Cryptosporidium and diarrhea versus HIV-infected subjects without Cryptosporidium infection or diarrhea
Time frame: 5 days
Clofazimine in plasma will be assessed via Cmax and time to reach Cmax (Tmax).
Pharmacokinetics (Ke) of Clofazimine in HIV-infected subjects with Cryptosporidium and diarrhea versus HIV-infected subjects without Cryptosporidium infection or diarrhea
Time frame: 5 days
Clofazimine in plasma will be assessed via Ke determined after the last dose on day 5.
Stool pharmacokinetics of Clofazimine in HIV-infected subjects with Cryptosporidium and diarrhea versus HIV-infected subjects without Cryptosporidium infection or diarrhea
Time frame: 5 days
The total daily amount of CFZ eliminated in stool will be assessed on Study Day 2 (2nd dose day), Study Day 5 (last dose day), and Study Day 6 (concentration of CFZ in stool before discharge).
Frequency and severity of solicited adverse events (AEs)
Time frame: 5 days
Frequency and severity of solicited AEs throughout study product administration
Frequency, severity, and relationship to study product of unsolicited AEs
Time frame: 55 days
Frequency, severity, and relationship to study product of unsolicited AEs throughout the course of the study
Occurrence of serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), and adverse events of special interest (AESI).
Time frame: 55 days
Occurrence of SAEs, SUSARs, and AESIs throughout the course of the study. AESI include: QT prolongation measured via 12-lead electrocardiogram, liver toxicity, skin discoloration and other skin related AEs/abnormalities (subjects will be evaluated for discoloration of skin of the palms and of the sclera and oral mucous membranes), GI-related AEs.

4 secondary outcomes

Evaluation of time to negative ELISA signal in subjects randomized to Clofazimine versus placebo
Time frame: 6 days
Characterization of the reduction in the number of diarrheal episodes following administration of CFZ relative to placebo.
Time frame: 6 days
Characterization of the stool volume following administration of CFZ relative to placebo.
Time frame: 6 days
Characterization of the stool consistency following administration of CFZ relative to placebo.
Time frame: 6 days

Results and safety

The study was stopped early (reason given: Insufficient accrual rate). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
Background: PubMed 28158186Love MS, Beasley FC, Jumani RS, Wright TM, Chatterjee AK, Huston CD, Schultz PG, McNamara CW. A high-throughput phenotypic screen identifies clofazimine as a potential treatment for cryptosporidiosis. PLoS Negl Trop Dis. 2017 Feb 3;11(2):e0005373. doi: 10.1371/journal.pntd.0005373. eCollection 2017 Feb.
Derived from this study: PubMed 34748385Zhang CX, Love MS, McNamara CW, Chi V, Woods AK, Joseph S, Schaefer DA, Betzer DP, Riggs MW, Iroh Tam PY, Van Voorhis WC, Arnold SLM. Pharmacokinetics and Pharmacodynamics of Clofazimine for Treatment of Cryptosporidiosis. Antimicrob Agents Chemother. 2022 Jan 18;66(1):e0156021. doi: 10.1128/AAC.01560-21. Epub 2021 Nov 8.
Derived from this study: PubMed 32277809Iroh Tam P, Arnold SLM, Barrett LK, Chen CR, Conrad TM, Douglas E, Gordon MA, Hebert D, Henrion M, Hermann D, Hollingsworth B, Houpt E, Jere KC, Lindblad R, Love MS, Makhaza L, McNamara CW, Nedi W, Nyirenda J, Operario DJ, Phulusa J, Quinnan GV, Sawyer LA, Thole H, Toto N, Winter A, Van Voorhis WC. Clofazimine for Treatment of Cryptosporidiosis in Human Immunodeficiency Virus Infected Adults: An Experimental Medicine, Randomized, Double-blind, Placebo-controlled Phase 2a Trial. Clin Infect Dis. 2021 Jul 15;73(2):183-191. doi: 10.1093/cid/ciaa421.
Derived from this study: PubMed 30139372Nachipo P, Hermann D, Quinnan G, Gordon MA, Van Voorhis WC, Iroh Tam PY. Evaluating the safety, tolerability, pharmacokinetics and efficacy of clofazimine in cryptosporidiosis (CRYPTOFAZ): study protocol for a randomized controlled trial. Trials. 2018 Aug 23;19(1):456. doi: 10.1186/s13063-018-2846-6.
Individual participant dataSharing planned: No

Related trials for Cryptosporidiosis

Not yet recruitingPhase 3
Nitazoxanide for Treatment of Cryptosporidium in Children
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RecruitingPhase 2
Study Testing the Efficacy, Safety, and Tolerability of EDI048 in Cryptosporidium Infection Model in Healthy Adults
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RecruitingObservational study
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RecruitingPhase 2
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Active, not recruitingObservational study
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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.

Wes Van Voorhis, MD, PhD principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Clofazimine in people with Cryptosporidiosis, run by University of Washington at 1 site in Malawi.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. 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: stopped early, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: Insufficient accrual rate). Results are not available in the source record.

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.

What does the primary outcome measure?

Reduction in Cryptosporidium fecal shedding following Clofazimine administration (time frame: 5 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03341767, which also lists 4 linked publications.

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 13 Aug 2019.