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This is an open label randomized controlled clinical trial comparing two regimens for treatment of smear-positive pulmonary TB, among patients previously treated for TB. The primary objective is to determine if a moxifloxacin-containing regimen, substituting moxifloxacin for ethambutol, of 24 weeks duration is superior to a control regimen of 24 weeks duration in improving treatment outcomes in patients with recurrent TB and shortens the duration of TB treatment.
Intervention Arm :12 months (6 months treatment + 12 months post treatment follow up) Control Arm :12 months (6 months treatment + 12 months post treatment follow up) Total sample size is 330.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxifloxacin | Active Comparator | A Moxifloxacin-containing oral regimen of Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Moxifloxacin (M), substituting Moxifloxacin for Ethambutol, daily for 24 weeks, see information below. Intensive phase 7 days a week for 8 weeks Continuation phase - 7 days a week for 16 weeks RH(150,75mg), Z (500mg), M (400mg) Dosage and number of tablets dispensed is dependent on participants weight band. |
|
| Ethambutol | Active Comparator | An Ethambutol oral regimen of Isoniazid (H), Rifampicin(R), Pyrazinamide (Z), Ethambutol(E), daily for 24 weeks duration, substituting Ethambutol for Moxifloxacin. Intensive phase 7 days a week for 8 weeks Continuation phase - 7 days a week for 16 weeks.See details below. (150,75,400,275 mg) RHZE Dosage and number of tablets dispensed is dependent on participants weight band. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| moxifloxacin | Drug | [isoniazid (H), rifampicin (R), pyrazinamide (Z), moxifloxacin (M)] |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sputum Culture Conversion Rates at Week 8 and Month 6 Post Tuberculosis Treatment Initiation | The proportion of patients with negative sputum cultures at the end of the intensive phase (8 weeks) and the proportion of patients with negative sputum cultures at 6 months were compared between the two study arms. All participants with sputum culture results at week 8 and month 6 were included in the analysis. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Culture-conversion of the Moxifloxacin Regimen and the Ethambutol Regimen | To determine the time to culture-conversion of the moxifloxacin regimen and the ethambutol regimen. | Up to 2 years |
| Proportion of Patients With Any Grade 3 or 4 Adverse Reactions in the Two Study Arms |
Not provided
Inclusion Criteria:
Adults ≥ 18 years of age
Previous history of anti-TB chemotherapy
HIV status: HIV infected and uninfected patients are allowed in the study:
All patients must agree to HIV testing to confirm HIV status.
Patients already on ARVs will be allowed in the study provided that the ART regimen is not contraindicated with any of the study agents .
HIV infected patients at any CD4 count irrespective of ART commencement and duration will be included in the study
Smear positive or Gene Xpert positive pulmonary tuberculosis
Rifampicin susceptible as determined by Gene Xpert at screening. Gene Xpert will be used to determine rifampicin resistance, hence the study team will made aware of resistance within 48 hours and prior to study enrolment.
Karnofsky score greater than 70
Female candidates of reproductive potential must agree to use two reliable methods of contraception while on study: a barrier method of contraception (condoms or cervical cap) together with another reliable form of contraceptive (condoms with a spermicidal agent, a diaphragm or cervical cap with spermicide, an Intrauterine Device (IUD), or hormone-based contraceptive)
A negative pregnancy test
Laboratory parameters done at, or 14 days prior to, screening:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nesri Padayatchi, MBChB, MSc | Centre for the AIDS Programme of Research in South Africa | Principal Investigator |
| Kogieleum Naidoo, MBChB | Centre for the AIDS Programme of Research in South Africa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAPRISA eThekwini Clinical Research Site (eCRS) | Durban | KwaZulu-Natal | 4001 | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37480005 | Derived | Rambaran S, Maseko TG, Lewis L, Hassan-Moosa R, Archary D, Ngcapu S, Garrett N, McKinnon LR, Padayatchi N, Naidoo K, Sivro A. Blood monocyte and dendritic cell profiles among people living with HIV with Mycobacterium tuberculosis co-infection. BMC Immunol. 2023 Jul 21;24(1):21. doi: 10.1186/s12865-023-00558-z. | |
| 30809633 | Derived |
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One individual in the control arm was terminated one month after enrollment owing to discovery of pre-existing violation of entry criteria. The individual was excluded from all statistical analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Moxifloxacin | A Moxifloxacin-containing oral regimen of Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Moxifloxacin (M), substituting Moxifloxacin for Ethambutol. The intervention arm substituted moxifloxacin for ethambutol (moxifloxacin group), and consisted of daily doses of moxifloxacin, rifampicin, isoniazid and pyrazinamide for 8 weeks, followed by daily doses of moxifloxacin, rifampicin and isoniazid for 16 weeks. Participants in the moxifloxacin arm received daily 400 mg of moxifloxacin (Avelox®, Bayer Healthcare), weight-based rifampicin at 450 or 600 mg, and 225 or 300 mg of isoniazid, for participants 38-54 and ≥55 kg, respectively, during the 2-month intensive phase and 4-month continuation phase of TB treatment. During the intensive phase of treatment, pyrazinamide was used at 1500 and 2000mg in participants between 38-54 and ≥55 kg, respectively. |
| FG001 | Control | An Ethambutol oral regimen of Isoniazid (H), Rifampicin(R), Pyrazinamide (Z), Ethambutol(E), substituting Ethambutol for Moxifloxacin. Daily doses of rifampicin, isoniazid, pyrazinamide and ethambutol for 8 weeks (intensive phase), followed by daily doses of rifampicin and isoniazid for 16 weeks (Continuation phase). During the first two months (intensive phase) of treatment, participants in the control arm received the following weight-based doses by fixed dose combination tablets: Participants who were 38 - 54kg received rifampicin 450mg, isoniazid 225mg, pyrazinamide 1200mg, ethambutol 825mg; participants who were 54 - 70kg received rifampicin 600mg, isoniazid 300mg, pyrazinamide 1600mg, ethambutol 1100mg; participants who were > 70 kg received rifampicin 750mg, isoniazid 375mg, pyrazinamide 2000mg, ethambutol 1375mg. During the subsequent four months (continuation phase), participants continued on the same weight-based doses of rifampicin and isoniazid. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Moxifloxacin | A Moxifloxacin-containing oral regimen of Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Moxifloxacin (M), substituting Moxifloxacin for Ethambutol. The intervention arm substituted moxifloxacin for ethambutol (moxifloxacin group), and consisted of daily doses of moxifloxacin, rifampicin, isoniazid and pyrazinamide for 8 weeks, followed by daily doses of moxifloxacin, rifampicin and isoniazid for 16 weeks. Participants in the moxifloxacin arm received daily 400 mg of moxifloxacin (Avelox®, Bayer Healthcare), weight-based rifampicin at 450 or 600 mg, and 225 or 300 mg of isoniazid, for participants 38-54 and ≥55 kg, respectively, during the 2-month intensive phase and 4-month continuation phase of TB treatment. During the intensive phase of treatment, pyrazinamide was used at 1500 and 2000mg in participants between 38-54 and ≥55 kg, respectively. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sputum Culture Conversion Rates at Week 8 and Month 6 Post Tuberculosis Treatment Initiation | The proportion of patients with negative sputum cultures at the end of the intensive phase (8 weeks) and the proportion of patients with negative sputum cultures at 6 months were compared between the two study arms. All participants with sputum culture results at week 8 and month 6 were included in the analysis. | Nine participants had missing data at week 8: 4 missed visits, 3 terminated before week 8 and 2 had MOTT cultured. Fourteen had missing data at month 6: 7 were terminated before month 6 and 7 missed their visits. | Posted | Count of Participants | Participants | 24 weeks |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Moxifloxacin | A Moxifloxacin-containing oral regimen of Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Moxifloxacin (M), substituting Moxifloxacin for Ethambutol. The intervention arm substituted moxifloxacin for ethambutol (moxifloxacin group), and consisted of daily doses of moxifloxacin, rifampicin, isoniazid and pyrazinamide for 8 weeks, followed by daily doses of moxifloxacin, rifampicin and isoniazid for 16 weeks. Participants in the moxifloxacin arm received daily 400 mg of moxifloxacin (Avelox®, Bayer Healthcare), weight-based rifampicin at 450 or 600 mg, and 225 or 300 mg of isoniazid, for participants 38-54 and ≥55 kg, respectively, during the 2-month intensive phase and 4-month continuation phase of TB treatment. During the intensive phase of treatment, pyrazinamide was used at 1500 and 2000mg in participants between 38-54 and ≥55 kg, respectively. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA2 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA2 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mrs Nonhlanhla Yende-Zuma | CAPRISA | 0027312604392 | Nonhlanhla.Yende@caprisa.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 11, 2015 | Feb 26, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 2, 2018 | Feb 26, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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Not provided
| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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To compare the proportion of patients with any Grade 3 or 4 adverse reactions in the two study arms. Outcome measured in terms of number of participants with at least one grade 3 or 4 events, and not in number of events. |
| Up to 2 years |
| Number of Participants With Adverse Events and 8-week Culture Conversion Rates Among HIV-infected Patients vs. HIV-uninfected Patients | To compare adverse events and 8-week culture conversion rates among HIV-infected patients vs. HIV-uninfected patients. The proportion of participants with at least one grade 3 or 4 adverse event was measured. | up to 2 years for adverse events and 8 weeks for culture conversion rates |
| Proportion of Patients With Unfavourable Outcomes or Tuberculosis Recurrence in the Moxifloxacin and Control Arm. | A patient was defined as having an unfavourable outcome if he/she was not cured at the end of treatment or did not successfully complete treatment. Recurrence after completion of treatment was defined as two positive cultures within a period of four months without an intervening negative culture. | up to 2 years |
| Perumal R, Padayatchi N, Yende-Zuma N, Naidoo A, Govender D, Naidoo K. A Moxifloxacin-based Regimen for the Treatment of Recurrent, Drug-sensitive Pulmonary Tuberculosis: An Open-label, Randomized, Controlled Trial. Clin Infect Dis. 2020 Jan 1;70(1):90-98. doi: 10.1093/cid/ciz152. |
| 30767706 | Derived | Naidoo A, Chirehwa M, Ramsuran V, McIlleron H, Naidoo K, Yende-Zuma N, Singh R, Ncgapu S, Adamson J, Govender K, Denti P, Padayatchi N. Effects of genetic variability on rifampicin and isoniazid pharmacokinetics in South African patients with recurrent tuberculosis. Pharmacogenomics. 2019 Mar;20(4):225-240. doi: 10.2217/pgs-2018-0166. Epub 2019 Feb 15. |
| Withdrawal by Subject |
|
| Relocation |
|
| Rifampicin resistant on culture |
|
| Patient Incarcerated |
|
| BG001 | Control | An Ethambutol oral regimen of Isoniazid (H), Rifampicin(R), Pyrazinamide (Z), Ethambutol(E), substituting Ethambutol for Moxifloxacin. Daily doses of rifampicin, isoniazid, pyrazinamide and ethambutol for 8 weeks (intensive phase), followed by daily doses of rifampicin and isoniazid for 16 weeks (Continuation phase). During the first two months (intensive phase) of treatment, participants in the control arm received the following weight-based doses by fixed dose combination tablets: Participants who were 38 - 54kg received rifampicin 450mg, isoniazid 225mg, pyrazinamide 1200mg, ethambutol 825mg; participants who were 54 - 70kg received rifampicin 600mg, isoniazid 300mg, pyrazinamide 1600mg, ethambutol 1100mg; participants who were > 70 kg received rifampicin 750mg, isoniazid 375mg, pyrazinamide 2000mg, ethambutol 1375mg. During the subsequent four months (continuation phase), participants continued on the same weight-based doses of rifampicin and isoniazid. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Control | An Ethambutol oral regimen of Isoniazid (H), Rifampicin(R), Pyrazinamide (Z), Ethambutol(E), substituting Ethambutol for Moxifloxacin. Daily doses of rifampicin, isoniazid, pyrazinamide and ethambutol for 8 weeks (intensive phase), followed by daily doses of rifampicin and isoniazid for 16 weeks (Continuation phase). During the first two months (intensive phase) of treatment, participants in the control arm received the following weight-based doses by fixed dose combination tablets: Participants who were 38 - 54kg received rifampicin 450mg, isoniazid 225mg, pyrazinamide 1200mg, ethambutol 825mg; participants who were 54 - 70kg received rifampicin 600mg, isoniazid 300mg, pyrazinamide 1600mg, ethambutol 1100mg; participants who were > 70 kg received rifampicin 750mg, isoniazid 375mg, pyrazinamide 2000mg, ethambutol 1375mg. During the subsequent four months (continuation phase), participants continued on the same weight-based doses of rifampicin and isoniazid. |
|
|
|
| Secondary | Time to Culture-conversion of the Moxifloxacin Regimen and the Ethambutol Regimen | To determine the time to culture-conversion of the moxifloxacin regimen and the ethambutol regimen. | Posted | Median | Inter-Quartile Range | weeks | Up to 2 years |
|
|
|
|
| Secondary | Proportion of Patients With Any Grade 3 or 4 Adverse Reactions in the Two Study Arms | To compare the proportion of patients with any Grade 3 or 4 adverse reactions in the two study arms. Outcome measured in terms of number of participants with at least one grade 3 or 4 events, and not in number of events. | Posted | Count of Participants | Participants | Up to 2 years |
|
|
|
|
| Secondary | Number of Participants With Adverse Events and 8-week Culture Conversion Rates Among HIV-infected Patients vs. HIV-uninfected Patients | To compare adverse events and 8-week culture conversion rates among HIV-infected patients vs. HIV-uninfected patients. The proportion of participants with at least one grade 3 or 4 adverse event was measured. | 9 participants had missing data at 8 weeks: 4 missed visits, 3 terminated before week 8, and 2 had MOTT cultured | Posted | Count of Participants | Participants | up to 2 years for adverse events and 8 weeks for culture conversion rates |
|
|
|
|
| Secondary | Proportion of Patients With Unfavourable Outcomes or Tuberculosis Recurrence in the Moxifloxacin and Control Arm. | A patient was defined as having an unfavourable outcome if he/she was not cured at the end of treatment or did not successfully complete treatment. Recurrence after completion of treatment was defined as two positive cultures within a period of four months without an intervening negative culture. | Posted | Count of Participants | Participants | up to 2 years |
|
|
|
|
| 6 |
| 98 |
| 27 |
| 98 |
| 30 |
| 98 |
| EG001 | Control | An Ethambutol oral regimen of Isoniazid (H), Rifampicin(R), Pyrazinamide (Z), Ethambutol(E), substituting Ethambutol for Moxifloxacin. Daily doses of rifampicin, isoniazid, pyrazinamide and ethambutol for 8 weeks (intensive phase), followed by daily doses of rifampicin and isoniazid for 16 weeks (Continuation phase). During the first two months (intensive phase) of treatment, participants in the control arm received the following weight-based doses by fixed dose combination tablets: Participants who were 38 - 54kg received rifampicin 450mg, isoniazid 225mg, pyrazinamide 1200mg, ethambutol 825mg; participants who were 54 - 70kg received rifampicin 600mg, isoniazid 300mg, pyrazinamide 1600mg, ethambutol 1100mg; participants who were > 70 kg received rifampicin 750mg, isoniazid 375mg, pyrazinamide 2000mg, ethambutol 1375mg. During the subsequent four months (continuation phase), participants continued on the same weight-based doses of rifampicin and isoniazid. | 4 | 98 | 12 | 98 | 19 | 98 |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA2 | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA2 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA2 | Non-systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA2 | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA2 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA2 | Non-systematic Assessment |
|
| Injection site paraesthesia | General disorders | MedDRA2 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA2 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA2 | Non-systematic Assessment |
|
| Treatment failure | General disorders | MedDRA2 | Non-systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA2 | Non-systematic Assessment |
|
| Nosocomial infection | Infections and infestations | MedDRA2 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA2 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA2 | Non-systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA2 | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA2 | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA2 | Non-systematic Assessment |
|
| Lung abscess | Infections and infestations | MedDRA2 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA2 | Non-systematic Assessment |
|
| Scrotal abscess | Infections and infestations | MedDRA2 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA2 | Non-systematic Assessment |
|
| Wound sepsis | Infections and infestations | MedDRA2 | Non-systematic Assessment |
|
| Disseminated tuberculosis | Infections and infestations | MedDRA2 | Non-systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA2 | Non-systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDRA2 | Non-systematic Assessment |
|
| Hepatitis B | Infections and infestations | MedDRA2 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA2 | Non-systematic Assessment |
|
| Epidemic vomiting syndrome | Infections and infestations | MedDRA2 | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA2 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA2 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA2 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA2 | Non-systematic Assessment |
|
| Neurological examination abnormal | Investigations | MedDRA2 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA2 | Non-systematic Assessment |
|
| Creatinine renal clearance decreased | Investigations | MedDRA2 | Non-systematic Assessment |
|
| Blood osmolarity decreased | Investigations | MedDRA2 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA2 | Non-systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA2 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA2 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA2 | Non-systematic Assessment |
|
| Optic neuritis | Nervous system disorders | MedDRA2 | Non-systematic Assessment |
|
| Trigeminal neuralgia | Nervous system disorders | MedDRA2 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA2 | Non-systematic Assessment |
|
| Acute psychosis | Psychiatric disorders | MedDRA2 | Non-systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA2 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA2 | Non-systematic Assessment |
|
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA2 | Non-systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA2 | Non-systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA2 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA2 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA2 | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA2 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA2 | Non-systematic Assessment |
|
| Bach's flower remedy | Surgical and medical procedures | MedDRA2 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA2 | Non-systematic Assessment |
|
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA2 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA2 | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA2 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA2 | Non-systematic Assessment |
|
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA2 | Non-systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA2 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA2 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA2 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA2 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA2 | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA2 | Non-systematic Assessment |
|
| Acute hepatic failure | Hepatobiliary disorders | MedDRA2 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA2 | Non-systematic Assessment |
|
| Sputum purulent | Infections and infestations | MedDRA2 | Non-systematic Assessment |
|
| Bone tuberculosis | Infections and infestations | MedDRA2 | Non-systematic Assessment |
|
| Disseminated tuberculosis | Infections and infestations | MedDRA2 | Non-systematic Assessment |
|
| Extrapulmonary tuberculosis | Infections and infestations | MedDRA2 | Non-systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDRA2 | Non-systematic Assessment |
|
| Hepatitis B | Infections and infestations | MedDRA2 | Non-systematic Assessment |
|
| Amylase increased | Investigations | MedDRA2 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA2 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA2 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA2 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA2 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA2 | Non-systematic Assessment |
|
| Creatinine renal clearance decreased | Investigations | MedDRA2 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA2 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA2 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA2 | Non-systematic Assessment |
|
| Hyperamylasaemia | Metabolism and nutrition disorders | MedDRA2 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA2 | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA2 | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA2 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA2 | Non-systematic Assessment |
|
| Female reproductive tract carcinoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA2 | Non-systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA2 | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA2 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA2 | Non-systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | MedDRA2 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA2 | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA2 | Non-systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA2 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA2 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA2 | Non-systematic Assessment |
|
Not provided
Not provided
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
|
| participants culture negative at 8 weeks |
|
|
Comparison of the 8-week culture conversion rates in the two arms, controlling for HIV status |
| Mantel Haenszel |
| 0.45 |
| Superiority |