Haemophilus Influenzae (NTHI)Phase 1/2NCT00905385
Nontypeable H. Influenzae in Healthy Adults
A Phase 1/2 study testing NTHi Strain 2019 in people with Haemophilus Influenzae (NTHI), run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to learn more about the safety of Haemophilus (H.) influenzae, its ability to produce adverse reactions and to live in the nose and throat. The nose and throat of healthy adults will be populated with a specific type of H. Read more about this study
- Who is it for?
- Ages 18 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Haemophilus Influenzae (NTHI)
- What is being tested?
- NTHi Strain 2019
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Mar 2011
- Phase
- Phase 1/2
- 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 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy 18-54 years old (male or female) with no chronic medical conditions with the exception of well-controlled hypertension
- Availability for study visits over the next 1 month
- Normal hemoglobin, white blood cell count, creatinine, alanine aminotransferase (ALT), platelet count
- Signed informed consent form
- In good health as determined by medical history and physical exam on the screening evaluation [including heart rate 55-100 beats per minute (bpm); blood pressure: systolic 90-140 mm Hg and diastolic 50-90 mm Hg]. If the subject is a well trained athlete by the judgment of the Principal Investigator (PI), heart rate of 40-100 bpm is acceptable.
- Negative urine pregnancy test for women of childbearing potential
Show all 20Show fewer
- If the subject is female and of childbearing potential, she agrees to use acceptable contraception and not become pregnant for the duration of the study. (Acceptable contraception includes abstinence, implants, injectables, combined oral contraceptives, effective intrauterine devices, or a vasectomized partner)
- Negative human immunodeficiency virus (HIV) enzyme linked immunosorbent assay (ELISA) for HIV 1 and 2 or indeterminate Western blot or other assay confirming that the serostatus does not reflect HIV infection, negative hepatitis C and hepatitis B serology or other assay confirming that the serostatus does not reflect active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection
- Negative urine protein and glucose by dipstick
- Subjects must be willing to be housed in the clinical research unit for the first 3 nights of the inoculation period.
- Healthy 18-54 years old (male or female) with no chronic medical conditions with the exception of well-controlled hypertension
- Normal hemoglobin, white blood cell count, creatinine, ALT, platelet count
- Negative HIV ELISA for HIV 1 and 2 or indeterminate Western blot or other assay confirming that the serostatus does not reflect HIV infection, negative hepatitis C and hepatitis B serology or other assay confirming that the serostatus does not reflect active HCV or HBV infection
- Negative urine protein and glucose by dipstick
- Availability for study visits over the next 1 month
- Signed informed consent form
- In good health as determined by medical history and physical exam on the screening evaluation (including heart rate 55-100 bpm; blood pressure: systolic 90-140 mm Hg and diastolic 50-90 mm Hg). If the subject is a well trained athlete by the judgment of the PI, heart rate of 40-100 bpm is acceptable.
- Negative urine pregnancy test for women of childbearing potential
- If the subject is female and of childbearing potential, she agrees to use acceptable contraception and not become pregnant for the duration of the study. (Acceptable contraception includes abstinence, implants, injectables, combined oral contraceptives, effective intrauterine devices, or a vasectomized partner)
- Subjects must be willing to spend 3-5 hours per day for 6 days in nonintimate contact with their paired inoculated contact.
Who cannot join
- Acute illness within the week prior to inoculation
- Acute febrile illness (oral temperature greater than or equal to 100.4 degrees Fahrenheit) on the day of inoculation
- Allergic rhinitis requiring therapy in the past year
- Treatment for sinusitis, otitis, chronic bronchitis, pneumonia, bronchospasm or asthma in the past 5 years
- Abnormal gag reflex
- Active drug or alcohol abuse
Show all 42Show fewer
- Smoking tobacco within the past year
- Average ingestion of more than one alcoholic beverage per day for women or two alcoholic beverages per day for men
- Splenectomy or disease that results in functional asplenism such as sickle cell diseases
- History of malignancy
- Human immunodeficiency virus (HIV) 1 or 2 infection, autoimmune, immunocompromising diseases, diabetes, or chronic renal, hepatic, pulmonary or cardiovascular diseases
- Uncontrolled depression or depression involving institutionalization, history of schizophrenia or psychosis, history of suicide attempt
- Pregnant or lactating woman
- Use of steroids (systemic, inhaled or intranasal) or other medications that can cause immunosuppression within the past 28 days
- American Indian, Native Alaskan or Native Australian heritage (aboriginal)
- Allergy to penicillin, macrolide, cephalosporin or fluoroquinolone antibiotics
- Use of any antibiotic within the past month
- Close contact (household, work or school contact/sexual contacts with, or frequent and/or prolonged exposure to) with persons less than 5 or greater than 55 years old; chronic smokers, Native Americans or other native populations outlined above, or those having HIV infection, cancer, chronic diseases or other illness causing immunosuppression; or having asthma or chronic lung disease. Specifically, child care and health care workers are excluded
- Use of experimental agents or devices within 30 days prior to study or anticipated use of experimental agents or devices within the 6 months of follow up for this study.
- Receipt of blood products or immunoglobulin in the past 6 months
- Any condition that, in the opinion of the investigator, might interfere with study objectives
- Prior participation in nontypeable Haemophilus influenzae colonization studies
- Acute illness or fever (oral temperature greater than or equal to 100.4 degrees Fahrenheit) within the week prior to inoculation for their paired inoculated contact
- Allergic rhinitis requiring therapy in the past year
- Treatment for sinusitis, otitis, chronic bronchitis, pneumonia, bronchospasm or asthma in the past 5 years
- Abnormal gag reflex
- Active drug or alcohol abuse
- Smoking tobacco within the past year
- Average ingestion of more than one alcoholic beverage per day for women or two alcoholic beverages per day for men
- Splenectomy or disease that results in functional asplenism such as sickle cell diseases
- History of malignancy
- HIV 1 or 2 infection, autoimmune, immunocompromising diseases, diabetes, or chronic renal, hepatic, pulmonary or cardiovascular diseases
- Uncontrolled depression or depression involving institutionalization, history of schizophrenia or psychosis, history of suicide attempt
- Pregnant or lactating woman
- Use of steroids (systemic, inhaled or intranasal) or other medications that can cause immunosuppression within the past 28 days
- American Indian, Native Alaskan or Native Australian heritage (aboriginal)
- Allergy to penicillin, macrolide, cephalosporin or fluoroquinolone antibiotics
- Use of any antibiotic within the past month
- Close contact (household contact/sexual contact with, or frequent and/or prolonged exposure to) with persons less than 5 or greater than 55 years old; chronic smokers, Native Americans or other native populations outlined above, or those having HIV infection, cancer, chronic diseases or other illness causing immunosuppression; or having asthma or chronic lung disease
- Use of experimental agents or devices within 30 days prior to study or anticipated use of experimental agents or devices within the 6 months of follow up for this study
- Any condition that, in the opinion of the investigator, might interfere with study objectives
- Prior participation in nontypeable Haemophilus influenzae colonization studies
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa - Infectious Disease Clinic
Iowa City, Iowa, 52242-1009
About this study
Official title: Phase I/II Single-Site, Randomized and Double-Blinded Trial to Further Characterize the HCD50, HCD90 and Transmissibility of Nontypeable Haemophilus Influenzae in a Human Colonization Model in Healthy Adults
The purpose of this study is to learn more about the safety of Haemophilus (H.) influenzae, its ability to produce adverse reactions and to live in the nose and throat. The nose and throat of healthy adults will be populated with a specific type of H. influenzae Nontypeable Haemophilus influenzae (NTHi) 2019 Streptomycin Resistant (StrR) number 1. Researchers will study whether the germ settles in the nose and throat, whether it causes symptoms after it has been placed in the nose, how long the germs last in the nose and throat, and whether the body tries to produce a permanent defense to the germ. Volunteers will receive a lower dose (3,200 germs) or a higher dose (32,000 germs). Active participation will last about 28 days, including a 3 night hospital stay, additional follow-up visits, followed by a 6 month follow-up phone call. Study procedures will include blood samples, saliva samples, several nose washes and throat swabs.
Read the detailed description
Haemophilus (H.) influenzae continues to be a major human pathogen causing upper and lower respiratory tract diseases ranging from otitis media and sinusitis to invasive pneumonia. The inoculation by nasal droplets proposed in this trial will introduce the organism into the nasal mucosa, the natural host tissue for H. influenzae colonization. It is hypothesized that this inoculum will elicit the typical nasal colonization seen in healthy individuals. To further develop this colonization model, healthy adults devoid of chronic medical conditions that might predispose the subject to invasive disease, will be enrolled. This study is linked to Division of Microbiology and Infectious Diseases (DMID) protocol 04-022. Final safety and reactogenicity data from DMID 04-022, have been collated. This nasal colonization model evaluated 15 volunteers and determined that the model was safe in these individuals and identified a human colonizing dose (HCD) 50 and HCD 90. However, the confidence intervals for these HCD doses were broad. The goals of this study are to further characterize the safety of this trial and to further refine the HCD 50 and 90 doses. This study is a single-site, randomized and blinded study designed to develop a colonization model for Nontypeable Haemophilus influenzae (NTHi). Ten healthy young adults ages 18-54 will be enrolled and inoculated with either 3,200 colony forming units (CFU) or 32,000 CFU of NTHi strain 2019 Streptomycin Resistant (StrR) number 1 and will be followed with nasal wash and throat swabs to determine whether colonization with NTHi 2019 StrR number 1 develops. Subjects that meet enrollment criteria will be admitted to the inpatient clinical research unit to a private room to stay from day 0 thru the morning of day 3 (visits 2-5) to evaluate for reactogenicity after nasal inoculation. During the hospital stay, subjects will remain in respiratory isolation. On day 0, five volunteers will be inoculated at the lower dose, 3,200 CFU, and five will be inoculated with higher dose, 32,000 CFU. After inoculation, primary volunteers will be followed daily for 6 days (visits 2-8, days 0-6) for clinical assessment and culture. Days 4-6, inoculated volunteers will return on a daily basis for a review of reactogenicity parameters, solicitation of adverse events (AEs), a targeted physical exam and pharyngeal swab and nasal wash specimens will be obtained. On day 6, visit 8, after pharyngeal swab and nasal wash samples have been collected and women of child bearing potential have had a urine pregnancy test performed, inoculated volunteers will receive 3 days of levofloxacin to eradicate any potential colonizing study organisms. Participants will return on days 14 and 28 to assess for any AEs, a targeted physical exam will be performed and pharyngeal swab, nasal wash, blood and saliva will be collected. A telephone visit will be performed 6 months after inoculation. A substudy will be performed to evaluate whether casual contact can serve as a mechanism for transmission of NTHi 2019 StrR number 1 from a colonized individual to a casual contact. Three and up to 10 subjects will be recruited to this substudy. They will spend 3-5 hours per day for 6 days with the subject in nonintimate contact and will be followed with nasal wash and throat swabs to determine whether colonization with NTHi 2019 StrR develops. The primary objective of the study is to evaluate the safety and reactogenicity of NTHi Strain 2019 StrR number 1 administered by nasal drop inoculation. The secondary objectives are to: evaluate the frequency and duration of colonization with NTHi strain 2019 StrR number 1 and to establish a human colonizing dose 5
- Conditions
- Haemophilus Influenzae (NTHI)
- Being tested
- NTHi Strain 2019
- Keywords
- nontypeable Haemophilus influenzae, NTHi
- Medical subject headings
- Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTHi Strain 2019Biological
Nontypeable Haemophilus influenzae (NTHi) strain 2019 StrR Number 1 is an antibiotic susceptible clinical strain that has a point mutation in the rRNA that renders the isolate resistant to streptomycin. This agent will be introduced by nasal droplets.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose: 3,200 CFU | Experimental | 5 subjects inoculated with 3,200 colony forming units (CFU). Receives: Biological: NTHi Strain 2019 |
| High Dose: 32,000 CFU | Experimental | 5 subjects inoculated with 32,000 colony forming units (CFU). Receives: Biological: NTHi Strain 2019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects evaluated for reactogenicity using a standardized illness assessment form. Information on additional unexpected adverse events, new medications and any non-routine medical visits will be assessed.
Measured: From day 0 to 28 and at 6 months.
Secondary outcomes (2)
Frequency and duration of colonization with this bacterium in primary subjects. Nasal wash and pharyngeal swab specimens will be obtained for culture of NTHi 2019 StrR number 1.
Measured: Days 0, 3, 4, 5, 6, 14, and 28.
Transmission of NTHi 2019 StrR number 1 to close contacts evaluated.
Measured: Days 0, 3, 6, 10, 14, and 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startAug 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemophilus Influenzae (NTHI)Studies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905385
- Sponsor's protocol ID
- 07-0091
- Other IDs
- H flu Extension
- Status last verified
- Jul 2010
- First submitted
- 18 May 2009
- Last updated
- 11 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Single-Site, Randomized and Double-Blinded Trial to Further Characterize the HCD50, HCD90 and Transmissibility of Nontypeable Haemophilus Influenzae in a Human Colonization Model in Healthy Adults
- ClinicalTrials.gov ID
- NCT00905385
- Acronym / sponsor ID
- 07-0091
- Conditions
- Haemophilus Influenzae (NTHI)
- Keywords
- nontypeable Haemophilus influenzae, NTHi
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Aug 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 20 May 2009 (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.
The purpose of this study is to learn more about the safety of Haemophilus (H.) influenzae, its ability to produce adverse reactions and to live in the nose and throat. The nose and throat of healthy adults will be populated with a specific type of H. influenzae Nontypeable Haemophilus influenzae (NTHi) 2019 Streptomycin Resistant (StrR) number 1. Researchers will study whether the germ settles in the nose and throat, whether it causes symptoms after it has been placed in the nose, how long the germs last in the nose and throat, and whether the body tries to produce a permanent defense to the germ. Volunteers will receive a lower dose (3,200 germs) or a higher dose (32,000 germs). Active participation will last about 28 days, including a 3 night hospital stay, additional follow-up visits, followed by a 6 month follow-up phone call. Study procedures will include blood samples, saliva samples, several nose washes and throat swabs.
Detailed description
Haemophilus (H.) influenzae continues to be a major human pathogen causing upper and lower respiratory tract diseases ranging from otitis media and sinusitis to invasive pneumonia. The inoculation by nasal droplets proposed in this trial will introduce the organism into the nasal mucosa, the natural host tissue for H. influenzae colonization. It is hypothesized that this inoculum will elicit the typical nasal colonization seen in healthy individuals. To further develop this colonization model, healthy adults devoid of chronic medical conditions that might predispose the subject to invasive disease, will be enrolled. This study is linked to Division of Microbiology and Infectious Diseases (DMID) protocol 04-022. Final safety and reactogenicity data from DMID 04-022, have been collated. This nasal colonization model evaluated 15 volunteers and determined that the model was safe in these individuals and identified a human colonizing dose (HCD) 50 and HCD 90. However, the confidence intervals for these HCD doses were broad. The goals of this study are to further characterize the safety of this trial and to further refine the HCD 50 and 90 doses. This study is a single-site, randomized and blinded study designed to develop a colonization model for Nontypeable Haemophilus influenzae (NTHi). Ten healthy young adults ages 18-54 will be enrolled and inoculated with either 3,200 colony forming units (CFU) or 32,000 CFU of NTHi strain 2019 Streptomycin Resistant (StrR) number 1 and will be followed with nasal wash and throat swabs to determine whether colonization with NTHi 2019 StrR number 1 develops. Subjects that meet enrollment criteria will be admitted to the inpatient clinical research unit to a private room to stay from day 0 thru the morning of day 3 (visits 2-5) to evaluate for reactogenicity after nasal inoculation. During the hospital stay, subjects will remain in respiratory isolation. On day 0, five volunteers will be inoculated at the lower dose, 3,200 CFU, and five will be inoculated with higher dose, 32,000 CFU. After inoculation, primary volunteers will be followed daily for 6 days (visits 2-8, days 0-6) for clinical assessment and culture. Days 4-6, inoculated volunteers will return on a daily basis for a review of reactogenicity parameters, solicitation of adverse events (AEs), a targeted physical exam and pharyngeal swab and nasal wash specimens will be obtained. On day 6, visit 8, after pharyngeal swab and nasal wash samples have been collected and women of child bearing potential have had a urine pregnancy test performed, inoculated volunteers will receive 3 days of levofloxacin to eradicate any potential colonizing study organisms. Participants will return on days 14 and 28 to assess for any AEs, a targeted physical exam will be performed and pharyngeal swab, nasal wash, blood and saliva will be collected. A telephone visit will be performed 6 months after inoculation. A substudy will be performed to evaluate whether casual contact can serve as a mechanism for transmission of NTHi 2019 StrR number 1 from a colonized individual to a casual contact. Three and up to 10 subjects will be recruited to this substudy. They will spend 3-5 hours per day for 6 days with the subject in nonintimate contact and will be followed with nasal wash and throat swabs to determine whether colonization with NTHi 2019 StrR develops. The primary objective of the study is to evaluate the safety and reactogenicity of NTHi Strain 2019 StrR number 1 administered by nasal drop inoculation. The secondary objectives are to: evaluate the frequency and duration of colonization with NTHi strain 2019 StrR number 1 and to establish a human colonizing dose 5
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose: 3,200 CFU | Experimental | Biological: NTHi Strain 20195 subjects inoculated with 3,200 colony forming units (CFU). |
| High Dose: 32,000 CFU | Experimental | Biological: NTHi Strain 20195 subjects inoculated with 32,000 colony forming units (CFU). |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Healthy 18-54 years old (male or female) with no chronic medical conditions with the exception of well-controlled hypertension
- Availability for study visits over the next 1 month
- Normal hemoglobin, white blood cell count, creatinine, alanine aminotransferase (ALT), platelet count
- Signed informed consent form
- In good health as determined by medical history and physical exam on the screening evaluation [including heart rate 55-100 beats per minute (bpm); blood pressure: systolic 90-140 mm Hg and diastolic 50-90 mm Hg]. If the subject is a well trained athlete by the judgment of the Principal Investigator (PI), heart rate of 40-100 bpm is acceptable.
Key exclusion criteria (42 listed)
- Acute illness within the week prior to inoculation
- Acute febrile illness (oral temperature greater than or equal to 100.4 degrees Fahrenheit) on the day of inoculation
- Allergic rhinitis requiring therapy in the past year
- Treatment for sinusitis, otitis, chronic bronchitis, pneumonia, bronchospasm or asthma in the past 5 years
- Abnormal gag reflex
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 |
|---|---|---|
| NTHi Strain 2019Nontypeable Haemophilus influenzae (NTHi) strain 2019 StrR Number 1 is an antibiotic susceptible clinical strain that has a point mutation in the rRNA that renders the isolate resistant to streptomycin. This agent will be introduced by nasal droplets. | Biological | High Dose: 32,000 CFU, Low Dose: 3,200 CFU |
Primary outcome
Subjects evaluated for reactogenicity using a standardized illness assessment form. Information on additional unexpected adverse events, new medications and any non-routine medical visits will be assessed.
Time frame: From day 0 to 28 and at 6 months.
2 secondary outcomes
Frequency and duration of colonization with this bacterium in primary subjects. Nasal wash and pharyngeal swab specimens will be obtained for culture of NTHi 2019 StrR number 1.
Time frame: Days 0, 3, 4, 5, 6, 14, and 28.
Transmission of NTHi 2019 StrR number 1 to close contacts evaluated.
Time frame: Days 0, 3, 6, 10, 14, and 28.
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 11 Apr 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NTHi Strain 2019 in people with Haemophilus Influenzae (NTHI), run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 20 inclusion and 42 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: finished, as of the sponsor's last update on 11 Apr 2013. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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.
What does the primary outcome measure?
Subjects evaluated for reactogenicity using a standardized illness assessment form. Information on additional unexpected adverse events, new medications and any non-routine medical visits will be assessed. (time frame: From day 0 to 28 and at 6 months.). It is what the study was designed to measure, not a finding.
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 11 Apr 2013.