Tuberculosis, MeningealPhase 2/3ReDEFINeNCT02169882
High-dose Rifampicin for the Treatment of Tuberculous Meningitis: a Dose-finding Study
A Phase 2/3 study testing Rifampicin, Other TB drugs and Adjuvant dexamethasone in people with Tuberculosis, Meningeal, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
Tuberculous meningitis (TBM) is the most severe form of tuberculosis infection with high mortality. Current treatment regimens are not based on clinical trials. Rifampicin is a key drug for TBM, but its penetration into the brain is limited, suggesting that a higher dose may be more effective. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Tuberculosis, Meningeal
- What is being tested?
- Rifampicin, Other TB drugs and Adjuvant dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Dec 2014to 5 May 2017
- Phase
- Phase 2/3
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or Female, aged 15 years or above.
- Clinical suspicion of TBM and CSF/blood glucose ratio < 0.5.
- None or less than 3 days of anti-tuberculosis chemotherapy taken for the current infection.
- Patient or representative (if the patient is incapacitated) is willing and able to give informed consent for participation in the study.
- Willingness to allow storage of specimens.
Who cannot join
- Patients may not enter the study if any of the following apply:
- Liver dysfunction (ALT > 5 times upper limit); kidney dysfunction (eGFR < 50 ml/min)
- Pregnancy or breastfeeding (negative urine pregnancy test for all females of child-bearing age).
- Confirmed cryptococcus meningitis (LFA), or confirmed bacterial meningitis (microscopy).
- Rapid clinical deterioration at time of presentation (e.g. signs of sepsis, decreasing consciousness or signs of cerebral oedema, or herniation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double Blinded Phase 2b Clinical Trial Comparing Standard Dose With Two Higher Doses of Rifampicin for Treatment of Adults With Tuberculous Meningitis
Tuberculous meningitis (TBM) is the most severe form of tuberculosis infection with high mortality. Current treatment regimens are not based on clinical trials. Rifampicin is a key drug for TBM, but its penetration into the brain is limited, suggesting that a higher dose may be more effective.
There are several highly relevant, outstanding questions related to the appropriate dose of rifampicin for TBM, before a multicenter phase 3 trial can be performed. These are:
- Previous phase 2a randomized clinical trial (done in the same setting as this proposed study) suggests that high doses of intravenous rifampicin (600mg, circa 13 mg/mg) for TBM is safe and associated with a survival benefit in adults. Given that i.v. rifampicin is not readily available, this needs to be confirmed using an equivalent higher oral dose of rifampicin.
- Recent pharmacokinetic analysis of a continuation trial comparing 600 mg i.v. rifampicin with 750 mg and 900 mg oral rifampicin suggests that an even higher dose may be needed; but this has not been examined
- Based on those previous data, there is a need to explore a longer duration of high-dose rifampicin for a subsequent phase 3 randomized clinical trial; treatment response in the investigators previous trial suggest that the optimal duration may be > 14 days.
- There is a need to explore relevant treatment endpoints besides mortality including neurological, neuroradiological and inflammatory response.
- Conditions
- Tuberculosis, Meningeal
- Being tested
- Placebo, Rifampicin, Other TB drugs, Adjuvant dexamethasone
- Keywords
- Tuberculous meningitis, Rifampicin, Dose finding study, Pharmacokinetics
- Medical subject headings
- Tuberculosis, Meningeal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Patients receiving 450 mg rifampicin will receive additional 2 placebo tablets, while those who receive 900 mg rifampicin will receive 1 placebo tablet.
Patients receiving 1350 mg rifampicin will not receive any placebo tablet.
With this arrangement, every subject will receive 3 tablets of study drugs.
RifampicinDrug
Also called Rifampisin - Kimia Farma
Patients in experimental arms will receive either 1 or 2 additional tablets of rifampicin.
Placebo tablets will be added accordingly, so that every study subject will receive 3 tablets of rifampicin plus placebo as described in the Arms section.
Other TB drugsDrug
Along with study drug and placebo, patients will receive other oral TB drugs (INH, Ethambutol, and Pyrazinamide) and pyridoxin, in accordance to National TB Program guidelines for 6 months.
Unconscious subjects will receive oral drugs via nasogastric tubes (NGT)
Adjuvant dexamethasoneDrug
Patients will receive dexamethasone in decreasing dose (in 6-8 weeks, according to TBM severity grade on admission)
| Study group | Role | What they receive |
|---|---|---|
| Rifampicin 450 mg (standard dose) | Active comparator | Twenty patients will receive 1 tablet of 450 mg Rifampicin and 2 tablets of placebo once daily for 30 days.
Unconscious subjects will receive oral drugs via nasogastric tubes (NGT).
After completion of one-month treatment, patients will receive 1 tablet of 450 mg Rifampicin.
Along with study drug and placebo, patients will receive other oral TB drugs (INH, Ethambutol, and Pyrazinamide) and pyridoxin, in accordance to National TB Program guidelines for 6 months.
Patients will also receive dexamethasone in decreasing dose (in 6-8 weeks, according to TBM severity grade on admission) Receives: Drug: Placebo; Drug: Other TB drugs; Drug: Adjuvant dexamethasone |
| Rifampicin 900 mg per oral | Experimental | Twenty patients will receive 2 tablets of 450 mg Rifampicin and 1 tablet of placebo once daily for 30 days.
Unconscious subjects will receive oral drugs via nasogastric tubes (NGT)
After completion of one-month treatment, patients will receive 1 tablet of 450 mg Rifampicin.
Along with study drug and placebo, patients will receive other oral TB drugs (INH, Ethambutol, and Pyrazinamide) and pyridoxin, in accordance to National TB Program guidelines for 6 months.
Patients will also receive dexamethasone in decreasing dose (in 6-8 weeks, according to TBM severity grade on admission) Receives: Drug: Placebo; Drug: Rifampicin; Drug: Other TB drugs; Drug: Adjuvant dexamethasone |
| Rifampicin 1350 mg per oral | Experimental | Twenty patients will receive 3 tablets of 450 mg Rifampicin and 0 tablet of placebo once daily for 30 days.
Unconscious subjects will receive oral drugs via nasogastric tubes (NGT)
After completion of one-month treatment, patients will receive 1 tablet of 450 mg Rifampicin.
Along with study drug and placebo, patients will receive other oral TB drugs (INH, Ethambutol, and Pyrazinamide) and pyridoxin, in accordance to National TB Program guidelines for 6 months.
Patients will also receive dexamethasone in decreasing dose (in 6-8 weeks, according to TBM severity grade on admission) Receives: Drug: Rifampicin; Drug: Other TB drugs; Drug: Adjuvant dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rifampicin concentrations in plasma and cerebrospinal fluid (CSF)
The rifampicin concentrations in plasma are measured from blood samples that are obtained by intensive pharmacokinetic sampling at 6 sampling time points (h0, 1, 2, 4, 8, 12 post dose). CSF rifampicin concentration will be measured using CSF sample taken by means of lumbar puncture at hour 3-6 post dose at the same day of blood sampling.
Measured: Day 2 (+/- 1) after administration of study drugs
Secondary outcomes (7)
Rifampicin concentrations in plasma and CSF at steady-state
The rifampicin concentrations in plasma are measured from blood samples that are obtained by intensive pharmacokinetic sampling at 6 sampling time points (h0, 1, 2, 4, 8, 12 post dose). CSF rifampicin concentration will be measured using CSF sample taken by means of lumbar puncture at hour 3-6 post dose at the same day of blood sampling.
Measured: Day 10 (+/- 1) after starting treatment with study drugs
Grade 3 and 4 and serious adverse events
Determined by measurement of liver function, hematology, gastrointestinal intolerance and hypersensitivity at days 3, 7, 10, 14, 30, 45, and 60
Measured: Within 60 days
Mortality
Measured: 180 days
Neurological response
Neurological responses that show both improvement (e.g. time to resolution of comma, time to fever resolution) and worsening (time to development of neurological deficits) will be measured and recorded at days 3, 7, 30 and 60.
Measured: Within 60 days
Neuroradiological response
Development of infarction or other complication of TBM will documented by performing and comparing brain MRIs that will be done within the first 5 day and 60 day (+/- 5 days) after randomization
Measured: 60 days
Resolution of blood and CSF inflammatory response
Inflammatory response will be measured at day 0 and day 7
Measured: 7 days
Sensitivity of GeneXpert for diagnosing TBM
Every CSF sample from patients who come with suspicion of TBM will be inoculated in GeneXpert cartridge and standard culture measures (MODS), and the result will be compared.
Measured: Within 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study start1 Dec 2014
- Primary completion5 Nov 2016
- Study completion5 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis, MeningealStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Radboud University Medical Center
- Responsible party
- Sponsor
- Investigators
- Rovina Ruslami, M.D., PhD, Principal investigator, Faculty of Medicine Universitas Padjadjaran, Bandung, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169882
- Sponsor's protocol ID
- TB-201406.01
- Other IDs
- PGA-2000003601
- Acronym
- ReDEFINe
- Status last verified
- Dec 2016
- First submitted
- 15 Jun 2014
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ruslami R, Ganiem AR, Dian S, Apriani L, Achmad TH, van der Ven AJ, Borm G, Aarnoutse RE, van Crevel R. Intensified regimen containing rifampicin and moxifloxacin for tuberculous meningitis: an open-label, randomised controlled phase 2 trial. Lancet Infect Dis. 2013 Jan;13(1):27-35. doi: 10.1016/S1473-3099(12)70264-5. Epub 2012 Oct 25.
PubMed 23103177Dian S, Yunivita V, Ganiem AR, Pramaesya T, Chaidir L, Wahyudi K, Achmad TH, Colbers A, Te Brake L, van Crevel R, Ruslami R, Aarnoutse R. Double-Blind, Randomized, Placebo-Controlled Phase II Dose-Finding Study To Evaluate High-Dose Rifampin for Tuberculous Meningitis. Antimicrob Agents Chemother. 2018 Nov 26;62(12):e01014-18. doi: 10.1128/AAC.01014-18. Print 2018 Dec.
PubMed 30224533
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blinded Phase 2b Clinical Trial Comparing Standard Dose With Two Higher Doses of Rifampicin for Treatment of Adults With Tuberculous Meningitis
- ClinicalTrials.gov ID
- NCT02169882
- Acronym / sponsor ID
- ReDEFINe / TB-201406.01
- Conditions
- Tuberculosis, Meningeal
- Keywords
- Tuberculous meningitis, Rifampicin, Dose finding study, Pharmacokinetics
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Radboud University Medical Center
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 5 Nov 2016 (actual)
- Study completion
- 5 May 2017 (actual)
- First posted
- 23 Jun 2014 (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.
Tuberculous meningitis (TBM) is the most severe form of tuberculosis infection with high mortality. Current treatment regimens are not based on clinical trials. Rifampicin is a key drug for TBM, but its penetration into the brain is limited, suggesting that a higher dose may be more effective.
There are several highly relevant, outstanding questions related to the appropriate dose of rifampicin for TBM, before a multicenter phase 3 trial can be performed. These are:
- Previous phase 2a randomized clinical trial (done in the same setting as this proposed study) suggests that high doses of intravenous rifampicin (600mg, circa 13 mg/mg) for TBM is safe and associated with a survival benefit in adults. Given that i.v. rifampicin is not readily available, this needs to be confirmed using an equivalent higher oral dose of rifampicin.
- Recent pharmacokinetic analysis of a continuation trial comparing 600 mg i.v. rifampicin with 750 mg and 900 mg oral rifampicin suggests that an even higher dose may be needed; but this has not been examined
- Based on those previous data, there is a need to explore a longer duration of high-dose rifampicin for a subsequent phase 3 randomized clinical trial; treatment response in the investigators previous trial suggest that the optimal duration may be > 14 days.
- There is a need to explore relevant treatment endpoints besides mortality including neurological, neuroradiological and inflammatory response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rifampicin 450 mg (standard dose) | Active comparator | Drug: Placebo, Drug: Other TB drugs, Drug: Adjuvant dexamethasoneTwenty patients will receive 1 tablet of 450 mg Rifampicin and 2 tablets of placebo once daily for 30 days. Unconscious subjects will receive oral drugs via nasogastric tubes (NGT). After completion of one-month treatment, patients will receive 1 tablet of 450 mg Rifampicin. Along with study drug and placebo, patients will receive other oral TB drugs (INH, Ethambutol, and Pyrazinamide) and pyridoxin, in accordance to National TB Program guidelines for 6 months. Patients will also receive dexamethasone in decreasing dose (in 6-8 weeks, according to TBM severity grade on admission) |
| Rifampicin 900 mg per oral | Experimental | Drug: Placebo, Drug: Rifampicin, Drug: Other TB drugs, Drug: Adjuvant dexamethasoneTwenty patients will receive 2 tablets of 450 mg Rifampicin and 1 tablet of placebo once daily for 30 days. Unconscious subjects will receive oral drugs via nasogastric tubes (NGT) After completion of one-month treatment, patients will receive 1 tablet of 450 mg Rifampicin. Along with study drug and placebo, patients will receive other oral TB drugs (INH, Ethambutol, and Pyrazinamide) and pyridoxin, in accordance to National TB Program guidelines for 6 months. Patients will also receive dexamethasone in decreasing dose (in 6-8 weeks, according to TBM severity grade on admission) |
| Rifampicin 1350 mg per oral | Experimental | Drug: Rifampicin, Drug: Other TB drugs, Drug: Adjuvant dexamethasoneTwenty patients will receive 3 tablets of 450 mg Rifampicin and 0 tablet of placebo once daily for 30 days. Unconscious subjects will receive oral drugs via nasogastric tubes (NGT) After completion of one-month treatment, patients will receive 1 tablet of 450 mg Rifampicin. Along with study drug and placebo, patients will receive other oral TB drugs (INH, Ethambutol, and Pyrazinamide) and pyridoxin, in accordance to National TB Program guidelines for 6 months. Patients will also receive dexamethasone in decreasing dose (in 6-8 weeks, according to TBM severity grade on admission) |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female, aged 15 years or above.
- Clinical suspicion of TBM and CSF/blood glucose ratio < 0.5.
- None or less than 3 days of anti-tuberculosis chemotherapy taken for the current infection.
- Patient or representative (if the patient is incapacitated) is willing and able to give informed consent for participation in the study.
- Willingness to allow storage of specimens.
Key exclusion criteria (5 listed)
- Liver dysfunction (ALT > 5 times upper limit); kidney dysfunction (eGFR < 50 ml/min)
- Pregnancy or breastfeeding (negative urine pregnancy test for all females of child-bearing age).
- Confirmed cryptococcus meningitis (LFA), or confirmed bacterial meningitis (microscopy).
- Rapid clinical deterioration at time of presentation (e.g. signs of sepsis, decreasing consciousness or signs of cerebral oedema, or herniation)
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 |
|---|---|---|
| PlaceboPatients receiving 450 mg rifampicin will receive additional 2 placebo tablets, while those who receive 900 mg rifampicin will receive 1 placebo tablet. Patients receiving 1350 mg rifampicin will not receive any placebo tablet. With this arrangement, every subject will receive 3 tablets of study drugs. | Drug | Rifampicin 450 mg (standard dose), Rifampicin 900 mg per oral |
| RifampicinAlso: Rifampisin - Kimia FarmaPatients in experimental arms will receive either 1 or 2 additional tablets of rifampicin. Placebo tablets will be added accordingly, so that every study subject will receive 3 tablets of rifampicin plus placebo as described in the Arms section. | Drug | Rifampicin 1350 mg per oral, Rifampicin 900 mg per oral |
| Other TB drugsAlong with study drug and placebo, patients will receive other oral TB drugs (INH, Ethambutol, and Pyrazinamide) and pyridoxin, in accordance to National TB Program guidelines for 6 months. Unconscious subjects will receive oral drugs via nasogastric tubes (NGT) | Drug | Rifampicin 1350 mg per oral, Rifampicin 450 mg (standard dose), Rifampicin 900 mg per oral |
| Adjuvant dexamethasonePatients will receive dexamethasone in decreasing dose (in 6-8 weeks, according to TBM severity grade on admission) | Drug | Rifampicin 1350 mg per oral, Rifampicin 450 mg (standard dose), Rifampicin 900 mg per oral |
Primary outcome
Rifampicin concentrations in plasma and cerebrospinal fluid (CSF)
Time frame: Day 2 (+/- 1) after administration of study drugs
The rifampicin concentrations in plasma are measured from blood samples that are obtained by intensive pharmacokinetic sampling at 6 sampling time points (h0, 1, 2, 4, 8, 12 post dose). CSF rifampicin concentration will be measured using CSF sample taken by means of lumbar puncture at hour 3-6 post dose at the same day of blood sampling.
7 secondary outcomes
Rifampicin concentrations in plasma and CSF at steady-state
Time frame: Day 10 (+/- 1) after starting treatment with study drugs
Grade 3 and 4 and serious adverse events
Time frame: Within 60 days
Mortality
Time frame: 180 days
Neurological response
Time frame: Within 60 days
Neuroradiological response
Time frame: 60 days
Resolution of blood and CSF inflammatory response
Time frame: 7 days
Sensitivity of GeneXpert for diagnosing TBM
Time frame: Within 6 weeks
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 1 Jun 2017.
- Background: PubMed 23103177Ruslami R, Ganiem AR, Dian S, Apriani L, Achmad TH, van der Ven AJ, Borm G, Aarnoutse RE, van Crevel R. Intensified regimen containing rifampicin and moxifloxacin for tuberculous meningitis: an open-label, randomised controlled phase 2 trial. Lancet Infect Dis. 2013 Jan;13(1):27-35. doi: 10.1016/S1473-3099(12)70264-5. Epub 2012 Oct 25.
- Derived from this study: PubMed 30224533Dian S, Yunivita V, Ganiem AR, Pramaesya T, Chaidir L, Wahyudi K, Achmad TH, Colbers A, Te Brake L, van Crevel R, Ruslami R, Aarnoutse R. Double-Blind, Randomized, Placebo-Controlled Phase II Dose-Finding Study To Evaluate High-Dose Rifampin for Tuberculous Meningitis. Antimicrob Agents Chemother. 2018 Nov 26;62(12):e01014-18. doi: 10.1128/AAC.01014-18. Print 2018 Dec.
- Individual participant dataSharing planned: No
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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.
Rovina Ruslami, M.D., PhD principal investigator
Faculty of Medicine Universitas Padjadjaran, Bandung, Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rifampicin, Other TB drugs and Adjuvant dexamethasone in people with Tuberculosis, Meningeal, run by Universitas Padjadjaran at 1 site in Indonesia.
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 5 inclusion and 5 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 1 Jun 2017. 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 Indonesia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Rifampicin concentrations in plasma and cerebrospinal fluid (CSF) (time frame: Day 2 (+/- 1) after administration of study drugs). 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 NCT02169882, which also lists 2 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 1 Jun 2017.