Table 2.
Microfilarial Densitiesa
| Study Time Point | ITT (n = 167) |
Treatment-PP (n = 147) |
Treatment and-IVM-PP (n = 87) |
|||
|---|---|---|---|---|---|---|
| Doxycycline | Placebo | Doxycycline | Placebo | Doxycycline | Placebo | |
| Baseline | ||||||
| Mf positive | 47/84 (56.0%) | 48/83 (57.8%) | 40/71 (56.3%) | 43/76 (56.6%) | 20/42 (47.6%) | 23/45 (51.1%) |
| P valueb | P = .876 | P = 1.0 | P = .831 | |||
| Mean ± SD | 2.30 ± 6.29 | 3.23 ± 8.69 | 1.90 ± 4.35 | 3.46 ± 9.05 | 0.84 ± 2.66 | 3.27 ± 10.51 |
| GMc | 0.78 | 1.03 | 0.75 | 1.08 | 0.4 | 0.82 |
| Min–Max | 0–45.62 | 0–65.99 | 0–24.87 | 0–65.99 | 0–17.02 | 0–65.99 |
| Median | 0.15 | 0.26 | 0.14 | 0.27 | 0 | 0.13 |
| 25th, 75th percentiles | 0, 1.11 | 0, 1.94 | 0, 1.11 | 0, 2.00 | 0, 0.63 | 0, 0.97 |
| P valued | P = .495 | P = .544 | P = .498 | |||
| 12 mo | ||||||
| Mf positive | 8/73 (11.0%) | 44/72 (61.1%) | 7/69 (10.1%) | 42/70 (60.0%) | 1/40 (2.5%) | 24/44 (54.5%) |
| P valueb | P < .001 | P < .001 | P < .001 | |||
| Mean ± SD | 0.87 ± 3.74 | 4.50 ± 8.11 | 0.90 ± 3.85 | 4.33 ± 8.10 | 0.70 ± 4.43 | 4.01 ± 7.24 |
| GMc | 0.21 | 1.68 | 0.21 | 1.58 | 0.09 | 1.47 |
| Min–Max | 0–28.00 | 0–38.63 | 0–28.00 | 0–38.63 | 0–28.00 | 0–33.86 |
| Median | 0 | 0.96 | 0 | 0.81 | 0 | 0.52 |
| 25th, 75th percentiles | 0, 0 | 0, 4.50 | 0, 0 | 0, 4.11 | 0, 0 | 0, 5.71 |
| P valued | P < .001 | P < .001 | P < .001 | |||
| 20 mo | ||||||
| Mf positive | 5/76 (6.6%) | 50/74 (67.6%) | 2/67 (3.0%) | 47/70 (67.1%) | 1/42 (2.4%) | 27/45 (60.0%) |
| P valueb | P < .001 | P < .001 | P < .001 | |||
| Mean ± SD | 0.75 ± 4.57 | 3.99 ± 9.05 | 0.56 ± 4.35 | 3.88 ± 9.12 | 0.85 ± 5.49 | 1.87 ± 4.24 |
| GMc | 0.12 | 1.35 | 0.07 | 1.29 | 0.09 | 0.83 |
| Min–Max | 0–35.60 | 0–46.58 | 0–35.60 | 0–46.58 | 0–35.60 | 0–24.46 |
| Median | 0 | 0.65 | 0 | 0.52 | 0 | 0.21 |
| 25th, 75th percentiles | 0, 0 | 0, 2.91 | 0, 0 | 0, 2.41 | 0, 0 | 0, 1.24 |
| P valued | P < .001 | P < .001 | P < .001 | |||
| Persistently Mf positivee | 1/69 (1.4%) | 24/69 (34.8%) | 0/65 (0%) | 24/68 (35.3%) | 0/40 (0%) | 15/44 (34.1%) |
Abbreviations: GM, geometric mean; ITT, intention to treat; IVM, ivermectin; Mf, microfilariae; PP, per protocol; SD, standard deviation.
a The ITT set includes all patients who received the study drugs for at least 1 day. The Treatment-PP set includes all people who took the treatment according to protocol and on this basis another set was created, only including people who also took part in both rounds of mass drug administration between treatment and 20 months of follow-up (Treatment and IVM-PP).
b Fisher exact test.
c The GM was calculated by adding 1 to all values and after the calculation 1 was again subtracted from the result.
d Mann–Whitney U test.
e Number of participants who were persistently Mf positive over all 3 timepoints.