Table 5.
Randomized clinical trials of azithromycin for the treatment of Neisseria gonorrhoeae
| Study (year) | Country | Year(s) | Azithromycin dose | Number cured of evaluated | Percent cured | 95% CI | Diagnostic methods | Additional details | Ref. |
|---|---|---|---|---|---|---|---|---|---|
| Dose of 2 g azithromycin | |||||||||
| Khaki et al. (2007) | India | 2005–2006 | 2 g | 22/22 | 100% | NA | Gram stain TOC days 5–7 |
[143] | |
| Handsfield et al. (1994) | USA | 1991–1992 | 2 g | 370/374 | 98.9% | 97.3–99.6% | [63] | ||
| Dose of 1 g azithromycin | |||||||||
| Rustomjee et al. (2002) | South Africa | 1999 | 1 g | 30/31 |
96.8% | 83.8–99.2% | LCR for NG/CT TOC day 14 |
100% (n = 21) NG infections cured 100% (n = 14) CT infections cured 90.0% (n = 10; 95% CI: 58.7–97.8%) co-infections cured |
[60] |
| Swanston et al. (2001) | Trinidad and Tobago | 1996 | 1 gram | 125/127 |
98.4% | 94.5–99.5% | ELISA for NG culture for CT; TOC days 7–10 | 100% (n = 115) NG infections cured 95.7% (n = 23; 95% CI: 78.9–99.0%) CT infections cured 88.3% (n = 12; 95% CI: 54.6–95.0%) co-infections cured |
[53] |
| Gruber et al. (1997) | Croatia | 1994–1995 | 1 g | 48/50 | 96.0% | 86.5–98.8% | Culture and gram stain for NG; TOC day 14 | [58] | |
| Gruber et al. (1995) | Croatia | 1991–1993 | 1 g | 24/24 | 96.0% | 80.4–99.1% | Culture and gram stain for NG; TOC day 14 | [57] | |
| Steingrimsson et al. (1994) | Iceland | NR | 1 g | 27/28 | 96.4% | 82.4–99.2% | Culture for NG w/ DFA; Culture for CT; TOC day 28 | 92.4% (n = 79; 84.4–96.4%) CT infections cured | [56] |
| Waugh et al. (1993) | UK | 1990–1991 | 1 g | 85/89 | 95.5% | 89.0–98.2% | Culture and gram stain for NG; culture for CT; TOC day 10 |
100% (n = 22) NG/CT co-infections cured |
[52] |
| Odugbemi et al. (1993) | Nigeria | 1989–1990 | 1 g | 114/120 | 95.0% | 89.5–97.6% | Culture for NG; TOC day 14 | [51] | |
| Steingrimsson et al. (1990) | Iceland | NR | 1 g (day 0) | 11/12 | 91.7% | 64.0–98.1% | Culture for NG/CT; TOC day 28 |
97.7% (n = 44; 88.2–99.5%) CT infections cured | [55] |
| 500 mg (day 0 x 2) | 7/8 | 87.5% | 51.8–97.2% | 96.3% (n = 27; 81.7–99.1%) CT infections cured | |||||
| 500 mg (day 0) 250 mg (days 1 and 2) | 7/7 | 100% | NA | 88.0% (n = 25; 69.8–95.6%) CT infections cured | |||||
| Lassus et al. (1990) | Finland | NR | 1 g (day 0) | 15/15 | 100% | NA | Culture and gram stain for NG/CT w/ DFA; TOC day 14 | 100% (n = 12) CT infections cured 100% (n = 5) co-infections cured |
[54] |
| 500 mg (day 0) 250 mg (days 1 and 2) |
14/14 | 100% | NA | 100% (n = 9) CT infections cured 83.3% (n = 6; 95% CI: 42.1–96.3%) co-infections cured |
|||||
CT: Chlamydia trachomatis; DFA: Direct fluorescent antibody; ELISA: Enzyme-linked immunosorbent assay; LCR: Ligase chain reaction; mg: milligrams; NA: Not applicable NG: Neisseria gonorrhoeae; NR: Not reported; TOC: Test of cure.