Appendix 15. Monitoring of patients on DR-TB treatment

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    Update: June 2023

     

    A cross "X" with no brackets indicates that the exam should be performed in all patients.
    A cross between brackets "(X)" indicates that the exam should only be performed in certain patients.

     

     BaselineTreatmentEnd of
    treatment    		Post  treatment(a)Citation a.For patients on BPaLM or BPaL regimen. 
    W1W2W3W4W5W6W7M2M3Until end of treatmentM6M12
    Clinical visits

    Vital signs, weight, etc.

    X

    X

    X

    X

    X

     

    X

     

    X

    X

    At each visit

    X

    X

    X

    Adverse effects

     

    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)

    		(X)

     

    		(X)

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

    (X)

     

     

     

    (X)

     

     

     

    (X)

    (X)

    (Monthly)

    		(X)

     

    		(X)

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

    (X)

     

     

     

    (X)

     

     

     

    (X)

    (X)

    (Monthly)

    		(X)

     

    		(X)

    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

     

     

    		 
    • aFor patients on BPaLM or BPaL regimen. 
    • bFor patients on Lzd.
    • cFor patients on E, Lzd or thionamides: visual acuity and colour vision deficiency.
    • dFor patients on Am or S.
    • eElectrocardiogram, 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.
    • fRapid 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.
    • gFor first- and second-line drugs. Repeat if culture is positive at Month 4 or later.
    • hAt baseline, then every 6 months:
      • Chest: for patients with PTB,
      • Bone: for patients with osteoarticular or spinal TB.
    • iFor 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.
    • jFor all patients: AST and ALT (and bilirubin if AST or ALT are elevated).
    • kFor all patients at baseline. Repeat if indicated. For patients on Am or S: once a month or more frequently if indicated.
    • lFor all patients to detect diabetes. If diabetes is detected, monitor according to standard protocols.
    • mFor all patients, unless documented HIV, hepatitis B and C status; HIV test every 6 months in high HIV prevalence areas.
    • nFor HIV-infected patients.
    • oFor patients on thionamides or PAS.
    • pFor adolescents and women of childbearing age. Repeat if indicated.
    Path