Appendix 15. Monitoring of patients on DR-TB treatment

Vital signs, weight, etc.

X

X

X

X

X

X

X

X

At each visit

X

X

X

Adverse events

X

X

X

X

X

X

X

At each visit

X

X

X

BPNS ^{(b) Citation b. For patients on Lzd.}

(X)

(X)

(X)

(X)

(Monthly)

Visual function tests ^{(c) Citation c. For patients on E, Lzd or thionamides: visual acuity and colour vision deficiency.}

(X)

(X)

(X)

(X)

(Monthly)

Audiometry ^{(d) Citation d. For patients on Am or S.}

(X)

(X)

(X)

(X)

(Monthly)

ECG ^{(e) Citation e. Electrocardiogram, for patients taking:
• < 2 moderate or severe QT-prolonging TB drugs or < 3 QT-prolonging drugs (TB and non-TB): at baseline then monthly.
• ≥ 2 moderate or severe QT-prolonging TB drugs or ≥ 3 QT-prolonging drugs (TB and non-TB) or with other risk factors for QT prolongation or TdP: once a week for the first month, then once a month.}

(X)

(X)

(X)

(X)

(X)

(X)

(X)

(Monthly)

Bacteriological tests

Smear microscopy

X

X

X

X

Monthly

X

X

X

Culture

X

X

X

X

Monthly

X

X

X

Rapid molecular tests ^{(f) Citation f. Rapid molecular tests:
• Xpert MTB/RIF (or Ultra) and Xpert MTB/XDR (or GenoType MTBDRsl if Xpert MTB/XDR not available).
• Repeat Xpert MTB/XDR (or GenoType MTBDRsl) if culture or microscopy is positive at Month 4 or later.}

X

If culture or microscopy positive at M4 or later

Full pDST ^{(g) Citation g. For first- and second-line drugs. Repeat if culture is positive at Month 4 or later.}

X

If culture positive at M4 or later

Other investigations

Radiography ^{(h) Citation h. At baseline, then every 6 months:
• Chest: for patients with PTB,
• Bone: for patients with osteoarticular or spinal TB.}

X

(Every

6 months)

X

Full blood count ^{(i) Citation i. For all patients at baseline, then:
• Patients on Lzd: every 2 weeks for the first 2 months, then once a month.
• Patients on AZT: once a month for the first 2 months, then if indicated.}

X

(X)

(X)

(X)

(X)

(Monthly)

(X)

Liver function ^{(j) Citation j. For all patients: AST and ALT (and bilirubin if AST or ALT are elevated).}

X

(X)

(X)

(X)

(Monthly)

Serum creatinine and potassium ^{(k) Citation k. For all patients at baseline. Repeat if indicated. For patients on Am or S: once a month or more frequently if indicated.}

X

(X)

(X)

(X)

(Monthly)

HbA1c, blood glucose ^{(l) Citation l. For all patients to detect diabetes. If diabetes is detected, monitor according to standard protocols.}

X

HIV, HBV, HCV ^{(m) Citation m. For all patients, unless documented HIV, hepatitis B and C status; HIV test every 6 months in high HIV prevalence areas.}

X

If indicated

CD4 and viral load ^{(n) Citation n. For HIV-infected patients.}

(X)

(Every

6 months)

TSH ^{(o) Citation o. For patients on thionamides or PAS.}

(X)

(X)

(Every

3 months)

Pregnancy test ^{(p) Citation p. For adolescents and women of childbearing age. Repeat if indicated.}

X

If indicated