Phase IIb randomized trial of adjunct immunotherapy in patients with first-diagnosed tuberculosis, relapsed and multi-drug-resistant (MDR) TB

Butov, Dmitry A; Pashkov, Yuri N; Stepanenko, Anna L; Choporova, Aleksandra I; Butova, Tanya S; Batdelger, Dendev; Jirathitikal, Vichai; Bourinbaiar, Aldar S; Zaitzeva, Svetlana I

doi:10.1186/1476-8518-9-3

Journal of Immune Based Therapies and Vaccines

Table 1 Baseline and outcome characteristics of TB patients receiving V5 in combination with TB drugs for 30 days

From: Phase IIb randomized trial of adjunct immunotherapy in patients with first-diagnosed tuberculosis, relapsed and multi-drug-resistant (MDR) TB

No.	Sex	Age	Months on ATT prior to V5	Dx	TB drugs regime	Smear status		Liver size in cm over normal		Erythrocyte sedimentation rate (mm/h)		Lymphocytes (%)		Leukocytes (× 10⁹/L)		Hemoglobin (g/L)		Body weight (kg)		Total bilirubin (μmol/L)		ALT (mM/h/ml)
						before	after	before	after	before	after	before	after	before	after	before	after	before	after	before	after	before	after
1	M	43	0	1^stDx	HRZE	3	1	2	0	50	30	18	23	11.7	9.2	129	122	64	65	8.8	8.8	0.4	0.1
2	M	39	0	1^stDx	HRZE	3	1	0	1	17	16	28	25	4.4	5.4	142	139	65	66	9.9	8.8	0.2	0.6
3	M	44	1	1^stDx	HRZES	1	0	1	0	21	15	19	29	6.1	5.6	127	116	74	78	8.8	9.9	0.6	0.5
4	M	60	3	1^stDx	HRZES	3	0	1	0	27	20	29	31	6.1	6	144	122	71	74	8.8	8.8	0.7	0.1
5	F	27	1	1^stDx	HRZES	3	2	1	0	58	40	16	22	11	8	101	110	43	49	8.8	8.8	0.7	0.7
6	M	26	3	1^stDx	HRZES	3	1	3	1	15	6	30	37	11.6	6	158	140	66	69	8.8	12.1	0.9	1.7
7	M	57	1	1^stDx	HRZES	2	0	0	0	32	9	21	34	5.3	5.1	109	123	60	63	12.1	9.9	0.1	0.5
8	M	31	0	1^stDx	HRZES	1	0	0	0	36	26	21	29	7.5	6.6	134	136	62	68	8.8	9.9	0.3	0.4
9	M	39	0	1^stDx	HRZES	2	1	0	0	50	30	14	17	11.7	9.6	154	144	63	67	8.8	8.8	0.2	0.2
10	M	31	3	1^stDx	HRZES	3	0	0	0	37	2	33	46	9.7	4	145	151	64	67	9.9	8.8	0.4	0.4
11	M	59	0	1^stDx	HRZES	1	0	1	1	25	24	27	29	6.6	5.2	138	136	61	66	18.1	12.1	0.3	0.5
12	M	26	0	1^stDx	HRZES	3	0	3	1	19	9	24	21	5.7	6.0	156	153	70	73	8.8	8.8	1.3	0.7
13	M	51	1	1^stDx	HRZES	3	0	1	2	15	6	16	29	14.2	6.9	142	150	81	81	12.1	8.8	0.6	0.9
14	F	46	1	RTB	HRZES	3	0	0	0	17	3	17	21	8.3	7.7	103	110	52	58	8.8	8.8	0.3	0.1
15	F	54	0	RTB	RZEO	3	0	3	1	16	8	24	34	6.1	5.1	143	128	58	59	8.8	8.8	1.2	0.6
16	F	35	1	RTB	HRZEA	3	0	0	0	32	15	18	37	6.7	5.5	142	136	62	67	8.8	8.8	0.2	0.2
17	M	49	1	MDR	HRZEO	3	0	1	1	55	40	18	37	20.4	7.5	138	100	73	75	12.1	9.9	0.8	0.8
18	M	29	9	MDR	HEAOC	3	1	5	3	25	14	11	26	7.9	7.9	129	138	59	62	8.8	8.8	0.5	0.9
19	F	53	2	MDR	ZEPAO	0	0	0	0	19	17	35	31	4.4	5.8	139	167	55	59	14.3	10.4	0.3	0.4
20	M	29	0	MDR	ZEPAO	2	0	1	0	10	8	33	35	10	6.2	147	148	65	69	8.8	8.8	0.6	0.6
21	M	29	4	MDR	ZEPAO	2	0	3	0	25	17	26	37	10.1	6.8	135	133	57	60	9.9	8.8	1.3	0.6
22	M	49	1	MDR	ZEPO	1	0	2	0	24	17	12	26	5.3	4.9	159	137	72	74	14.2	9.9	1	0.6
23	M	52	0	MDR	ZPAO	1	0	3	1	24	18	24	26	5	4.2	124	128	68	73	13.5	8.8	1.4	0.7
24	M	22	1	MDR	CsCiGF	1	0	0	0	23	18	25	27	19.6	7.2	121	131	66	73	8.8	8.8	0.1	0.2
	5/19	Mean = 40.8 ± 12 Median = 41	Mean = 1.6 ± 2.5 Median = 1	1^stDx = 13 RTB = 3 MDR = 8		1/23 2.2/3	18/6 0.3/0	1.3 ± 1.4/1	0.5 ± 0.8/0	28 ± 13.4	17 ± 10.4	22.5 ± 6.8	29.5 ± 6.7	9 ± 4.3	6.4 ± 1.4	135.8 ± 15.8	133.3 ± 15.5	63.8 ± 7.9	67.3 ± 7.3	10.4 ± 2.5	9.4 ± 0.99	0.6 ± 0.4	0.54 ± 0.35
						P = 0.000027		P = 0.0018		P = 8.3E-007		P = 2.8E-005		P = 0.0024		P = 0.39		P = 2.3E-009		P = 0.03		P = 0.47

TB drugs used in this arm are abbreviated as follows: Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Ethambutol (E), Streptomycin (S), Ofloxacin (O), Amikacin (A), Capreomycin (C), Para-aminosalicylic acid (P), Cs (Cycloserine), Cilastatin (Ci), Gatifloxacin (G), Metronidazole (F), Prothionamide (Pt)

Back to article page