National T.B program guidelines INDUS HOSPITAL

SUSPECT AND CASE DEFINITIONS

Tuberculosis suspect

A suspect is any person who presents with symptoms or signs suggestive of TB. The most common symptom of pulmonary TB is a productive cough for more than 2 weeks¹, which may be accompanied by other respiratory symptoms (shortness of breath, chest pains, haemoptysis) and/or constitutional symptoms (loss of appetite, weight loss, fever, night sweats, and fatigue).²

Case of tuberculosis

A pulmonary case with one or more initial sputum smear examinations positive for acid-fast bacilli (AFB) is considered to be a “definite” case. ³ In settings with advanced laboratory capacity a patient with Mycobacterium tuberculosis complex can be identified from a clinical specimen, either by culture or by a newer method such as GeneXpert.

Pulmonary Tuberculosis (PTB)

Pulmonary tuberculosis (PTB) refers to a case of TB (defined above) involving the lung parenchyma. Miliary tuberculosis is classified as pulmonary TB because there are lesions in the lungs. Tuberculous intrathoracic lymphadenopathy (mediastinal and/or hilar) or tuberculous pleural effusion, without radiographic abnormalities in the lungs, constitutes a case of extrapulmonary TB. A patient with both pulmonary and extrapulmonary TB should be classified as a case of pulmonary TB.

Smear Positive / GeneXpert Positive Pulmonary TB

A case of pulmonary TB is considered to be positive if one or more sputum specimens at the start of treatment are positive for AFB on microscopy or GeneXpert testing.

 Smear Negative Pulmonary TB

A case of pulmonary TB is considered to be smear-negative if at least two sputum specimens at the start of treatment are negative for AFB along with any of the following:

a.       Radiographic abnormalities consistent with active pulmonary TB;

b.      Culture-positive for M. tuberculosis; and

c.       Decision by a clinician to treat with a full course of anti-TB therapy.

Extrapulmonary Tuberculosis (EPTB)

Extrapulmonary tuberculosis (EPTB) refers to a case of TB (defined above) involving organs other than the lungs, e.g. pleura, lymph nodes, abdomen, genitourinary tract, skin, joints and bones, meninges. Diagnosis should be based on at least one specimen with confirmed M. tuberculosis or histological or strong clinical evidence consistent with active EPTB, followed by a decision by a clinician to treat with a full course of tuberculosis chemotherapy. The case definition of an EPTB case with several sites affected depends on the site representing the most severe form of disease.

CASE DETECTION

As per the inclusion criteria, all patients with a productive cough of two weeks or more should be considered TB suspects. Other symptoms in addition to this may exist and mainly include:

•       Nights sweats

•       Fever

•       Weight loss

•       Haemoptysis

Diagnosis:

The process involved in diagnosing a confirmed TB patient can be broken down into several stages:

Bacteriology refers to the smear status of pulmonary cases and the identification of M. tuberculosis for any case by culture or newer methods. Standard 2 of the ISTC states that all patients suspected of having pulmonary TB should submit at least two sputum specimens for microscopic examination. When possible, at least one early-morning specimen should be obtained, as sputum collected at this time has the highest yield. ISTC Standard 4 states that all persons with chest radiographic findings suggestive of TB should submit sputum specimens for microbiological examination

Sputum-positive cases are the most infectious and most likely to transmit their disease in their surroundings; they are the focus for infection control measures and contact investigations. Bacteriological monitoring of treatment progress is most feasible and practicable in these patients. It is also important to identify smear-negative cases.The aims of treatment of tuberculosis are:

• to cure the patient and restore quality of life and productivity;
•  to prevent death from active TB or its late effects;

• to prevent relapse of TB;

• to reduce transmission of TB to others; and

• to prevent the development and transmission of drug resistance

TYPE OF TB PATIENT

a.       New case: If patient has never taken treatment for tuberculosis or has taken anti-tuberculosis drugs for less than four weeks in the past.

b.      Relapse: If patient declared cured or treatment completed in the past, again has a positive sputum smear.

c.       Transferred in: A patient who has been transferred from another TB register to continue treatment.

d.      Treatment After Failure: If patient while on treatment is sputum smear positive 5 months of later during the course of treatment OR smear negative patient found smear positive at completion of 2 months treatment.

e.       Treatment After Default: If patient returns to treatment after interrupting treatment for two months or more.

f.       Others: Patients who do not fit in the above mentioned types such as patients known to have taken Tb drugs for more than 4 weeks from outside the program.

 How to decide Type of Patient based on History of Drug Intake:

History of Drug Intake	Smear Result Now	Type of Patient
Never taken TB drugs in the past	Smear positive	New Case
Taken TB drugs for less than 4 weeks in the past	Smear negative
Taken full course of TB Treatment in the past and declared cured	Smear positive	Relapse
Taken TB drugs and transferred from another register	-	Transferred-in
Smear positive patient taken TB drugs for 5 months or more	Smear positive	Treatment failure
Smear negative patient taken drugs for 2 months
Taken drugs for more than 4 weeks then interrupted for 2/or more	Smear positive	Return after
Months		default
Taken drug for more than 4 weeks from outside program	Smear positive	Others
	Smear negative

CATEGORIZATION OF PATIENT

Once the TB suspect has been confirmed, in order to determine their drug prescription and treatment regimen, it is necessary to classify them into one of two categories: Category I and Category II. These are defined by the NTP as follows:

•       Category I: New case of smear positive pulmonary tuberculosis or smear negative pulmonary or extra pulmonary tuberculosis; and

•       Category II: Previous treatment for more than four weeks in the past, and is found sputum smear positive pulmonary tuberculosis. This category includes: relapse, failure, treatment after default, and others

Smear Results	Disease Classification	Patient Type	Category
		New	CAT - I
		Relapse	CAT - II
Positive	Pulmonary	Rx. after failure
		Rx. after default
		Others
Negative	Pulmonary or Extra-pulmonary	New	CAT – I

 REGIMEN

Fixed-Dose Regimen for Category 1 (Adults)

		Continuation
	Intensive Phase Daily (2	Phase Daily
	months)	(6 months)
Patient Bosy	RHZE	HR
Weight (kg)	R 150mg+H 75mg+ Z	H 150mg + R
	400mg+E 275mg	400mg
30-39	2	1.5
40-54	3	2
55-70	4	3
70+	5	3

Fixed-Dose Regimen for Category 2 (Adults)

			Continuation Phase Daily
	Intensive Phase Daily (3 months)		(5 months)
Patient Bosy	RHZE	S	RHE
Weight (kg)
	R 150mg+H 75mg+ Z	Streptomycin Injection 750mg only	R 150mg + H 75 mg + E
	400mg+E 275mg	for 2 months of Intensive Phase	275mg
30-39	2	500 mg	2
40-54	3	750 mg	3
55-70	4	750 mg	4
70+	5	750 mg	5

FOLLOW UP VISITS

The follow up for patient will take place according to schedule:

•       Follow up for Category 1 Patient: End of Month 2, 5 and 7; and

•       Follow up for Category 2 Patient: End of Month 3, 5 and 7

The following steps may be required during follow-up visits:

a.       Ascertain the regularity of drug intake

b.      Schedule next visit 

 c.      Starting Continuation Phase (When required)

d.     Managing patients not responding to TB drugs (When required)

e.      Declaring Outcomes (When required)

f.       Managing Side Effects

STARTING CONTINUATION PHASE OF TREATMENT

The following scheme should be followed in starting Continuation Phase:

Category of	Smear Result at the	Management
Patient	End of 2nd (or 3rd)
	month
Category 1	Negative at the end of 2	Start Continuation Phase Treatment
(smear positive)	months
	Positive at the end of 2	Continue Intensive Phase for 1 more month
	months	Re-examine sputum at the end of 3 month
		Then start continuation phase irrespective of smear result
Category 2	Negative at the end of 3	Start Continuation Phase Treatment
	month
	Positive at the end of 3	Continue Intensive Phase for 1 more month
	month	Re-examine sputum at the end of 4 month
		If negative, start Continuation Phase
		If positive, stop drugs for 7 days, refer to laboratory for
		Culture/Sensitivity and start Continuation Phase
Category 1	Negative at the end of 2	Start Continuation Phase Treatment
(smear	months
negative)
	Positive at the end of 2	Repeat sputum smear to confirm, if positive register as Category 2
	months

MANAGING PATIENTS FOUND NOT RESPONDING TO TB DRUGS

Category of	Smear Result at the	Management
Patient	End of 5th (or other)
	month
Category 1	Positive at the end of 5	Repeat smear to confirm positive
	months	If smear positive confirmed-Declare Failure
		Register as Category 2 patient
		Send for Culture/Sensitivity if possible
Category 2	Positive at the end of 5	Repeat smear to confirm positive
	months	If positive, Declare Failure
		Send for Culture/Sensitivity if possible

 DECLARING OUTCOMES

The following scheme should be followed in declaring outcomes:

		Sputum Results
Months	0		Follow up				Comments	Outcome
drugs taken
	month	month 2/3	month 5		month 8
		Neg	Neg or missed		Neg		-	Cured
6 months	Pos	Pos	Neg		Neg		-
		Neg	Neg or missed		Missed		-	Completed
	Neg	Neg	-		-		-
	Pos	Neg	Pos		-		-
		Pos	Pos		-		-	Failure
	Neg	Pos	-		-		-
						Has not collected
8 months						medicines for 2		Defaulted
						consecutive months
	Pos or	Smear results during follow up are not
						Died of any reason during		Died
	Neg	considered (in these 3 situations)
						the course of treatment
						Transferred to another TB		Transferred
						register		out

SIDE EFFECT MANAGEMENT

If the patient has a Side Effect	Then Manage as follows:
Minor Side Effects
Anorhexia, nausea, abdominal pain	Continue anti-TB drugs and give TB drugs last thing in the night
Joint pains	Aspirin
Burning sensation in the feet	Pyridoxine 100 mg daily
Itching	Anti-histamine
If no response, refer
Major Side Effects
Skin Rash
Deafness
Dizziness (Vertigo and Nystagmus)	Refer to Chest Specialist or Indus Hospital
Jaundice
Visual Impairment (other causes excluded)
Shock, purpura, acute renal failure
If Orange/Red urine, then reassure patient that this is normal