Intervention: Metronidazole
Trial phase: Phase 2
ATC code: A01AB17 | A02BD01 | A02BD02 | A02BD03 | A02BD08 | A02BD11 | A02BD13 | A02BD15 | D06BX01 | G01AF01 | G01AF20 | J01RA03 | J01RA04 | J01RA10 | J01RA14 | J01XD01 | P01AB01 | P01AB51 | P01AB52
SMILES: Cc1ncc([N+](=O)[O-])n1CCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Subjects were randomized to receive metronidazole 500 mg TID or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
Eligibility criteria:
INCLUSION CRITERIA:

Male and females age 20 and above
Signs or symptoms of tuberculosis (i.e., cough that has lasted 3 weeks or longer, hemoptysis, chest pain, fatigue, weight loss, night sweats)
Subjects with documented AFB smear-positive pulmonary tuberculosis at screening to NMTH
Radiographic evidence of tuberculous disease of the lung(s)
TB isolate resistant to at least isoniazid and rifampicin
Drug Susceptibility Testing (DST) results known for ofloxacin (can be either sensitive or resistant)
Ability and willingness to give written or oral informed consent
Willingness to be an inpatient at NMTH for, at minimum, the duration of study drug/placebo treatment
Willingness to have samples stored
Available for follow-up visits

EXCLUSION CRITERIA:

People who are unwilling or unable to abstain from alcohol consumption for the study drug treatment duration (8 weeks)
Women of childbearing potential, who are pregnant, breast feeding, or unwilling to avoid pregnancy by the use of appropriate contraception including oral and subcutaneous implantable hormonal contraceptives, condoms, diaphragm, intrauterine device (IUD), or abstinence from sexual intercourse at study screening and during the study drug/placebo treatment (two months with allowed stops) (Note: Prospective female participants of childbearing potential must have negative pregnancy test (urine) within 48 hours prior to study entry.)
Subjects with pan resistant isolates
Presently taking 2nd -line agents started more than 14 days prior to initial FDG-PET scan

People with any of the following in their current medical assessment:

Absolute neutrophil count less than 1000 cells/mL
White Blood Cell count (WBC) less than 3.0 X 10(3)/microliter
Hemoglobin less than 7.0 g/dL
Platelet count less than 75,000 cells/mm(3)
Serum creatinine greater than 2.0 mg/dL
Aspartate aminotransferase (AST or SGOT) greater than 100 IU/L
Alanine aminotransferase (ALT or SGPT) greater than 100 IU/L
Total bilirubin greater than 2 mg/dL
Moderate or severe peripheral neuropathy
HIV-1 or HIV-2 infection
History of systemic lupus erythematosus, rheumatoid arthritis, or other connective tissue disease
Terminal illness with impending mortality
History of allergy or serious adverse reaction to metronidazole or placebo formulation used in this study

The use of any of the following drugs within 30 days prior to study or anticipated use of these drugs within the next 60 days:

Systemic cancer chemotherapy
Systemic corticosteroids
Systemic investigational agents
Antiretroviral medications
Growth factors
HIV vaccines
Immune globulin
Interleukins
Interferons
The need for ongoing therapy with warfarin, phenytoin, lithium, cimetidine, disulfiram, ergot derivatives, cholestyramine, fosphenytoin, carbamazepine, cyclosporine, tacrolimus, sirolimus, amiodarone or phenobarbital while on study drug.
Any other serious systemic illness requiring treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy for at least 14 days prior to study entry
Unwilling to be an inpatient at NMTH for greater than or equal to 2 months
Any condition that the investigator believes would warrant exclusion