Appendix 14. Monitoring of patients on DS-TB treatment

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    Update: October 2022

     

    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.

     

      Baseline  Treatment  End of  
    treatment 
    W2 M1 M2 M3 M4 M5 M6 Until end of treatment(a)Citation a.For treatments longer than 6 months.
    Clinical visits 

    Vital signs, weight, etc.

    X

    X

    X

    X

    X

    X

    X

    X

    At each visit

    X

    Adverse effects 

    		  

    X

    X

    X

    X

    X

    X 

    X

    At each visit

    X

    Bacteriological tests

    Rapid molecular tests(b)Citation b.Rapid molecular tests:
    • Xpert MTB/RIF (or Ultra) and Xpert MTB/XDR (or GenoType MTBDRsl if Xpert MTB/XDR not available).
    • Repeat RMTs if microscopy or culture is positive at Month 2 or later.

    X

     

     

    (X)

     

     

     

     

     

     

    Smear microscopy

    X

     

     

    X

    		  

    X

    		  

    X

     

    X

    Culture and pDST(c)Citation c.Culture and pDST to first- and second-line drugs:
    • At baseline if RMTs are not available, to detect rifampicin and isoniazid resistance or rifampicin resistance mutations not detected by RMTs.
    • At Month 2 or later, if RMTs show a new resistance.   
    • At Month 4, if microscopy is still positive.

    (X)

     

     

    (X)

     

    (X)

     

     

     

     

    Other investigations 

    Radiography(d)Citation d.Radiography:
    • Chest: at baseline for children with presumed PTB, patients with non-bacteriologically confirmed PTB, suspicion of other intra-thoracic TB, then if indicated (e.g. worsening respiratory symptoms, non-response to TB treatment).
    • Bone: at baseline then every 6 months for patients with bone and joint TB.

    (X)

      

    		    

     

     

     

    (X)

    If

    indicated

    If indicated

    Full blood count(e)Citation e.For patients on AZT or rifabutin.

    (X)

     

    (X)

    (X)

     

     

     

     

    If

    indicated

     

    Liver function(f)Citation f.For patients with pre-existing hepatic disease: AST and ALT (and bilirubin if AST or ALT are elevated).

    (X)

      

    (X)

    (X)

    (X)

    (X)

    (X)

    (X)

    If

    indicated

    		  

    Serum creatinine(g)Citation g.For patients with renal insufficiency.

    (X)

     

     

     

     

     

     

     

    If

    indicated

     

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

    X

      

     

     

     

     

     

     

    If

    indicated

     

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

    X

    		  

     

     

     

     

     

     (X)

    If

    indicated  

     

    CD4 and viral load(j)Citation j.For HIV-infected patients.

    (X)

      

     

     

     

     

     

    (X)

    		  

    (X)
    • aFor treatments longer than 6 months.
    • bRapid molecular tests:
      • Xpert MTB/RIF (or Ultra) and Xpert MTB/XDR (or GenoType MTBDRsl if Xpert MTB/XDR not available).
      • Repeat RMTs if microscopy or culture is positive at Month 2 or later.
    • cCulture and pDST to first- and second-line drugs:
      • At baseline if RMTs are not available, to detect rifampicin and isoniazid resistance or rifampicin resistance mutations not detected by RMTs.
      • At Month 2 or later, if RMTs show a new resistance.   
      • At Month 4, if microscopy is still positive.
    • dRadiography:
      • Chest: at baseline for children with presumed PTB, patients with non-bacteriologically confirmed PTB, suspicion of other intra-thoracic TB, then if indicated (e.g. worsening respiratory symptoms, non-response to TB treatment).
      • Bone: at baseline then every 6 months for patients with bone and joint TB.
    • eFor patients on AZT or rifabutin.
    • fFor patients with pre-existing hepatic disease: AST and ALT (and bilirubin if AST or ALT are elevated).
    • gFor patients with renal insufficiency.
    • hFor all patients to detect diabetes. If diabetes is detected, monitor according to standard protocols.  
    • iFor all patients, unless documented HIV, hepatitis B and C status; HIV test every 6 months in high HIV prevalence areas. 
    • jFor HIV-infected patients.
    Path