Safety Surveillance of Mass Praziquantel and Albendazole Co-Administration in School Children from Southern Ethiopia: An Active Cohort Event Monitoring
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design, Area, and Population
2.2. Study Enrolment and Baseline Data Collection
2.3. Pre-Screening for S. mansoni and STH Infection
2.4. Mass Drug Administration and Safety Outcome Measures
- Grade 1—Mild: asymptomatic or mild symptoms; clinical or diagnostic observations only; and intervention not indicated.
- Grade 2—Moderate: limiting age-appropriate instrumental activities of daily living (ADL). Minimal, local, or non-invasive intervention indicated.
- Grade 3—Severe: medically significant but not immediately life-threatening: disabling and limiting the self-care activities of daily living. Hospitalization or prolongation of hospitalization indicated.
- Grade 4—Life-threatening consequences: urgent intervention indicated.
- Grade 5—Death related to an AE.
2.5. Statistical Analysis
3. Results
3.1. Baseline Characteristics of Study Participants
3.2. Cumulative Incidence of MDA-Associated AEs
3.3. Types of MDA-Associated Adverse Events
3.4. Adverse Events by S. mansoni and STH Infection Status
3.5. Severity Grading of Adverse Events
3.6. Factors Associated with MDA-Associated Adverse Events
3.7. Predictors of Adverse Events
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Variables | Category | Frequency N (%) |
---|---|---|
Sex | Male | 2956 (50.5) |
Female | 2892 (49.5) | |
Age Group | 5–9 years | 1046 (17.9) |
10–15 years | 4802 (82.1) | |
Enrolment site | Hawella Tula | 2306 (39.4) |
Wondo Gennet | 3542 (60.6) | |
Types of infection (n = 1484) | Non-infected | 419 (28.2) |
Schistosomiasis only | 211 (14.2) | |
STH only | 552 (37.2) | |
Schistosomiasis + STH | 302 (20.4) | |
Stunting status | Normal | 5228 (89.4) |
Stunted | 620 (10.6) | |
Wasting status | Normal | 5391 (92.2) |
Wasted | 457 (7.8) | |
Type of food eaten Pre MDA. | Carbohydrate | 5753 (98.4) |
Fatty meal | 50 (0.9) | |
Protein | 45 (0.8) | |
Pre MDA-Events | Yes | 129 (2.2) |
No | 5719 (97.2) |
Types of Adverse Events | Cumulative | Severity Grading | |||
---|---|---|---|---|---|
Number | Incidence | Mild (N/%) | Moderate (N/%) | Severe (N/%) | |
Headache | 358 | 6.1 | 319 (89.1) | 35 (9.8) | 4 (1.1) |
Abdominal pain | 334 | 5.7 | 294 (88.0) | 36 (0.8) | 4 (1.2) |
Vomiting | 116 | 2.0 | 88 (75.9) | 24 (20.7) | 4 (3.4) |
Dizziness | 92 | 1.6 | 80 (87.0) | 11 (12.0) | 1 (1.1) |
Nausea | 89 | 1.5 | 74 (83.1) | 13 (14.6) | 2 (2.2) |
Fever | 71 | 1.2 | 58 (81.7) | 12 (16.9) | 1 (1.4) |
Confusion | 30 | 0.5 | 27 (90.0) | 3 (10.0) | 0 |
Diarrhea | 29 | 0.5 | 20 (69.0) | 7 (24.1) | 2 (6.9) |
Itching | 21 | 0.4 | 21 (100) | 0 | 0 |
Drowsiness | 13 | 0.2 | 13 (100) | 0 | 0 |
Loss of appetite | 10 | 0.2 | 5 (50.0) | 4 (40.0) | 1(10.0) |
Rash | 4 | 0.1 | 4 (100) | 0 | 0 |
Difficulty Breathing | 3 | 0.1 | 2 (66.7) | 1 (33.3) | 0 |
Cough | 1 | 0 | 1 (100) | 0 | 0 |
Other symptoms | 16 | 0.3 | 13 (81.3) | 1 (6.3) | 2 (12.5) * |
Total | 1187 | 13.3 | 1019 (85.8) | 147 (12.4) | 21 (1.8) |
Variables | Category | Adverse Events | X2 | p-Value | |
---|---|---|---|---|---|
No (N/%) | Yes (N/%) | ||||
Total | 5068 (86.7) | 780 (13.3) | |||
Sex | Male | 2622 (88.7) | 334 (11.3) | 21.5 | <0.001 |
Female | 2446 (84.6) | 446 (15.4) | |||
Age group | 5–9 years | 938 (89.7) | 108 (10.3) | 10.0 | 0.002 |
10–15 years | 4130 (86.0) | 672 (14.0) | |||
Stunting | Normal | 4530 (86.6) | 698 (13.4) | 0.008 | 0.93 |
Stunted | 538 (86.8) | 82 (13.2) | |||
Wasting | Normal | 4653 (86.3) | 738 (13.7) | 7.4 | 0.007 |
Wasted | 415 (90.8) | 42 (9.2) | |||
Enrolment district | Hawella Tula | 1961 (85.0) | 345 (15.0) | 8.7 | 0.003 |
WondoGennet | 3107 (87.7) | 435 (12.3) | |||
Infection status (S.mansoni or STH) | Infected | 896 (84.1) | 169 (16.0) | 14.3 | <0.001 |
Non-infected | 384 (91.6) | 35 (8.4) | |||
Infection types | Non infected | 384 (91.6) | 35 (8.4) | 24.5 | <0.001 |
Schistosomiasis only | 163 (77.3) | 48 (22.7) | |||
STH only | 470 (85.1) | 82 (14.9) | |||
Schistosomiasis + STH | 263 (87.1) | 39 (12.9) | |||
Number of praziquantel tablet taken | <3 tablets | 2416 (87.1) | 357 (12.9) | 1 | 0.32 |
≥3 tablets | 2652 (86.2) | 423 (13.8) |
Variables | Category | Univariate Analysis | Multivariate Analysis | ||||
---|---|---|---|---|---|---|---|
cRR | 95% CI | p-Value | aRR | 95% CI | p-Value | ||
Sex | Male | 1 | |||||
Female | 1.4 | 1.2–1.6 | <0.001 | 1.3 | 1.0–1.7 | 0.04 | |
Age group | 5–9 years | 1 | |||||
10–15 years | 1.4 | 1.1–1.6 | 0.002 | 1.5 | 1.0–2.1 | 0.04 | |
Stunting (HAZ) | Normal | 1 | |||||
Stunted | 1.0 | 0.8–1.2 | 0.93 | ||||
Wasting (BAZ) | Normal | 1 | |||||
Wasted | 0.7 | 0.5–0.9 | 0.008 | 1.3 | 0.8–2.1 | 0.3 | |
Type of meal eaten before MDA. | Carbohydrate | 1 | |||||
Fatty meal | 1.2 | 0.6–2.2 | 0.6 | ||||
Protein | 0.8 | 0.4–1.9 | 0.7 | ||||
S.mansoniand/or STH Infection | Non-Infected | 1 | |||||
Infected | 1.8 | 1.3–2.6 | <0.001 | ||||
Type of Infection | Negatives | ||||||
SM only | 2.6 | 1.8–3.9 | <0.001 | 2.5 | 1.7–3.7 | <0.001 | |
SM + STH | 1.5 | 0.97–2.3 | 0.07 | 1.5 | 1.2–2.5 | 0.005 | |
STH only | 1.7 | 1.2–2.5 | 0.003 | 1.7 | 0.98–2.3 | 0.057 | |
Number of praziquanltel tablets | <3 tablets | ||||||
≥3 tablets | 1.1 | 0.9–1.6 | 0.32 |
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Gebreyesus, T.D.; Makonnen, E.; Tadele, T.; Gashaw, H.; Degefe, W.; Gerba, H.; Tadesse, B.T.; Gurumurthy, P.; Aklillu, E. Safety Surveillance of Mass Praziquantel and Albendazole Co-Administration in School Children from Southern Ethiopia: An Active Cohort Event Monitoring. J. Clin. Med. 2022, 11, 6300. https://doi.org/10.3390/jcm11216300
Gebreyesus TD, Makonnen E, Tadele T, Gashaw H, Degefe W, Gerba H, Tadesse BT, Gurumurthy P, Aklillu E. Safety Surveillance of Mass Praziquantel and Albendazole Co-Administration in School Children from Southern Ethiopia: An Active Cohort Event Monitoring. Journal of Clinical Medicine. 2022; 11(21):6300. https://doi.org/10.3390/jcm11216300
Chicago/Turabian StyleGebreyesus, Tigist Dires, Eyasu Makonnen, Tafesse Tadele, Habtamu Gashaw, Workagegnew Degefe, Heran Gerba, Birkneh Tilahun Tadesse, Parthasarathi Gurumurthy, and Eleni Aklillu. 2022. "Safety Surveillance of Mass Praziquantel and Albendazole Co-Administration in School Children from Southern Ethiopia: An Active Cohort Event Monitoring" Journal of Clinical Medicine 11, no. 21: 6300. https://doi.org/10.3390/jcm11216300