Trial Outcomes & Findings for Evaluation of Effectiveness of ALBENDAZOLIVERMECTIN Coformulation vs ALBENDAZOLE for Treatment of Intestinal Worms (NCT NCT05124691)

Last Updated: 2025-09-22

Results Overview

For Trichuris trichiura, the cure rate is defined as the proportion of participants who test negative for T. trichiura eggs in the Kato-Katz fecal examination on day 21 post-treatment, relative to the total number of participants infected at baseline (n=636).

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

1001 participants

Primary outcome timeframe

21 days

Results posted on

2025-09-22

Participant Flow

Participant milestones

Participant milestones
Measure	Albendazole Single dose of Albendazole 400mg	Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) Single dose 400mg Albendazole- 9mg Ivermectin for participants \<45 kg of body weight Single dose 400mg Albendazole- 18mg Ivermectin for participants \>= 45 kg of body weight	Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) Daily dose of 400mg Albendazole- 9mg Ivermectin for 3 consecutive days for participants \<45 kg of body weight Daily dose of 400mg Albendazole- 18mg Ivermectin for 3 consecutive days for participants \>= 45 kg of body weight
Phase II STARTED	30	51	54
Phase II Received Any Study Drug After Randomization	27	50	51
Phase II COMPLETED	24	48	51
Phase II NOT COMPLETED	6	3	3
Phase III STARTED	213	330	323
Phase III Received Any Study Drug After Randomization	213	330	323
Phase III COMPLETED	206	326	319
Phase III NOT COMPLETED	7	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Albendazole Single dose of Albendazole 400mg	Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) Single dose 400mg Albendazole- 9mg Ivermectin for participants \<45 kg of body weight Single dose 400mg Albendazole- 18mg Ivermectin for participants \>= 45 kg of body weight	Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) Daily dose of 400mg Albendazole- 9mg Ivermectin for 3 consecutive days for participants \<45 kg of body weight Daily dose of 400mg Albendazole- 18mg Ivermectin for 3 consecutive days for participants \>= 45 kg of body weight
Phase II Eligibility criteria	0	1	0
Phase II Withdrawal by Subject	6	2	3
Phase III Withdrawal by Subject	6	4	4
Phase III Lost to Follow-up	1	0	0

Baseline Characteristics

Phase II (n=135) and Phase III (n=866) data are shown separately

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 21 days

Population: Intention to treat population infected with Trichuris trichiura from both Phase II and Phase III of the study (n=636). A separate efficacy analysis by phase was not conducted, as the protocol specifies that the required sample size for this outcome is derived from all participants infected with T. trichiura at baseline, combining those from Phase II and Phase III.

Outcome measures

Outcome measures
Measure	Albendazole n=131 Participants Single dose of Albendazole 400mg	Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) n=251 Participants Single dose 400mg Albendazole- 9mg Ivermectin for participants \<45 kg of body weight Single dose 400mg Albendazole- 18mg Ivermectin for participants \>= 45 kg of body weight	Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) n=254 Participants Daily dose of 400mg Albendazole- 9mg Ivermectin for 3 consecutive days for participants \<45 kg of body weight Daily dose of 400mg Albendazole- 18mg Ivermectin for 3 consecutive days for participants \>= 45 kg of body weight
Cure Rate for T. Trichiura (CR)	47 Participants	208 Participants	247 Participants

PRIMARY outcome

Timeframe: 21 days postreatment

Population: Intention-to-Treat (ITT) population from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis).

Proportions of participants presenting at least one treatment-related adverse event by arm

Outcome measures

Outcome measures
Measure	Albendazole n=243 Participants Single dose of Albendazole 400mg	Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) n=381 Participants Single dose 400mg Albendazole- 9mg Ivermectin for participants \<45 kg of body weight Single dose 400mg Albendazole- 18mg Ivermectin for participants \>= 45 kg of body weight	Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) n=377 Participants Daily dose of 400mg Albendazole- 9mg Ivermectin for 3 consecutive days for participants \<45 kg of body weight Daily dose of 400mg Albendazole- 18mg Ivermectin for 3 consecutive days for participants \>= 45 kg of body weight
Frequency of Related Adverse Events ITT Phase II and Phase III	34 Participants	75 Participants	88 Participants
Frequency of Related Adverse Events ITT Phase II	3 Participants	8 Participants	10 Participants
Frequency of Related Adverse Events ITT Phase III	31 Participants	67 Participants	78 Participants

SECONDARY outcome

Timeframe: 21 days

The Egg Reduction Rate (ERR) is defined as the percentage reduction in the geometric mean (GM) of eggs per gram (EPG) of feces from baseline to post-treatment.

Outcome measures

Outcome measures
Measure	Albendazole n=131 Participants Single dose of Albendazole 400mg	Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) n=251 Participants Single dose 400mg Albendazole- 9mg Ivermectin for participants \<45 kg of body weight Single dose 400mg Albendazole- 18mg Ivermectin for participants \>= 45 kg of body weight	Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) n=254 Participants Daily dose of 400mg Albendazole- 9mg Ivermectin for 3 consecutive days for participants \<45 kg of body weight Daily dose of 400mg Albendazole- 18mg Ivermectin for 3 consecutive days for participants \>= 45 kg of body weight
Egg Reduction Rate for T. Trichiura (ERR)	83.4 Percentage of reduction Interval 73.7 to 89.8	99.2 Percentage of reduction Interval 98.9 to 99.5	99.9 Percentage of reduction Interval 99.8 to 99.9

SECONDARY outcome

Timeframe: 21 days

Population: Intention to treat population infected with hookworm from Phase III of the study (n=350). A separate efficacy analysis by phase was not conducted, as the protocol specifies that the required sample size for this outcome is derived exclusively from participants infected with hookworms at baseline in Phase III.

For hookworm, the cure rate is defined as the proportion of participants who test negative for hookworm eggs in the Kato-Katz fecal examination on day 21 post-treatment, relative to the total number of participants infected at baseline in Phase III (n=350).

Outcome measures

Outcome measures
Measure	Albendazole n=106 Participants Single dose of Albendazole 400mg	Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) n=124 Participants Single dose 400mg Albendazole- 9mg Ivermectin for participants \<45 kg of body weight Single dose 400mg Albendazole- 18mg Ivermectin for participants \>= 45 kg of body weight	Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) n=120 Participants Daily dose of 400mg Albendazole- 9mg Ivermectin for 3 consecutive days for participants \<45 kg of body weight Daily dose of 400mg Albendazole- 18mg Ivermectin for 3 consecutive days for participants \>= 45 kg of body weight
Cure Rate for for Hookworm (CR)	69 Participants	99 Participants	114 Participants

SECONDARY outcome

Timeframe: 21 days

The Egg Reduction Rate (ERR) is defined as the percentage reduction in the geometric mean (GM) of eggs per gram (EPG) of feces from baseline to post-treatment.

Outcome measures

Outcome measures
Measure	Albendazole n=106 Participants Single dose of Albendazole 400mg	Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) n=124 Participants Single dose 400mg Albendazole- 9mg Ivermectin for participants \<45 kg of body weight Single dose 400mg Albendazole- 18mg Ivermectin for participants \>= 45 kg of body weight	Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) n=120 Participants Daily dose of 400mg Albendazole- 9mg Ivermectin for 3 consecutive days for participants \<45 kg of body weight Daily dose of 400mg Albendazole- 18mg Ivermectin for 3 consecutive days for participants \>= 45 kg of body weight
Egg Reduction Rate for Hookworm (ERR)	97.8 Percentage of reduction Interval 96.6 to 98.7	99.0 Percentage of reduction Interval 98.2 to 99.4	99.8 Percentage of reduction Interval 99.5 to 99.9

SECONDARY outcome

Timeframe: 21 days

Population: Intention to treat population infected with S. stercoralis from Phase III of the study (n=97). A separate efficacy analysis by phase was not conducted, as the protocol specifies that the required sample size for this outcome is derived exclusively from participants infected with S. stercoralis at baseline in Phase III.

For S. stercoralis, the cure rate is defined as the proportion of participants who test negative for S. stercoralis larvae in the Baermann tesi on day 21 post-treatment, relative to the total number of participants infected at baseline in Phase III (n=97).

Outcome measures

Outcome measures
Measure	Albendazole n=16 Participants Single dose of Albendazole 400mg	Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) n=40 Participants Single dose 400mg Albendazole- 9mg Ivermectin for participants \<45 kg of body weight Single dose 400mg Albendazole- 18mg Ivermectin for participants \>= 45 kg of body weight	Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) n=41 Participants Daily dose of 400mg Albendazole- 9mg Ivermectin for 3 consecutive days for participants \<45 kg of body weight Daily dose of 400mg Albendazole- 18mg Ivermectin for 3 consecutive days for participants \>= 45 kg of body weight
Cure Rates for for S. Stercoralis	13 Participants	38 Participants	41 Participants

SECONDARY outcome

Timeframe: 21 days

Population: For Trichuris trichiura, the cure rate is defined as the proportion of participants who test negative by qPCR (Ct-value\>35) on day 21 post-treatment, relative to the total number of participants that were positves at baseline by Kato-Katz and qPCR (n=534).

For Trichuris trichiura, the cure rate is defined as the proportion of participants who test negative by qPCR (Ct-value\>35) on day 21 post-treatment, relative to the total number of participants that were positves at baseline by Kato-Katz and qPCR (n=534).

Outcome measures

Outcome measures
Measure	Albendazole n=110 Participants Single dose of Albendazole 400mg	Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) n=203 Participants Single dose 400mg Albendazole- 9mg Ivermectin for participants \<45 kg of body weight Single dose 400mg Albendazole- 18mg Ivermectin for participants \>= 45 kg of body weight	Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) n=221 Participants Daily dose of 400mg Albendazole- 9mg Ivermectin for 3 consecutive days for participants \<45 kg of body weight Daily dose of 400mg Albendazole- 18mg Ivermectin for 3 consecutive days for participants \>= 45 kg of body weight
Cure Rate for T. Trichiura (CR) by qPCR	55 Participants	152 Participants	188 Participants

SECONDARY outcome

Timeframe: 21 days

Population: Although samples were collected from participants, they were not analyzed and will not be analyzed in the future, as emerging scientific evidence has invalidated the hypothesis.

The original objective as per the protocol was to "To evaluate the frequency of known ALB resistant alleles in hookworm and T. trichiura in the three treatment arms before and after treatment" with the endpoint being "Evaluation of genotypic albendazole resistance in the three arms." This objective was based on the hypothesis that mutations at codons 167, 198, and 200 of the beta-tubulin gene of Trichuris trichiura were associated with resistance. However, since this time, it has become increasingly evident, based on research from us (PMID: 35895348, 39546832, 34563247) and others, that this hypothesis is no longer supported, and that the genetic determinants of resistance in T. trichiura are yet to be discovered. Therefore, we have begun evaluating, using whole genome sequencing, other genetic variants and their association with poor treatment response. This research is exploratory and ongoing. Therefore, the original outcome as defined in the protocol could not be assessed.

Outcome measures

Outcome data not reported

Adverse Events

Albendazole

Serious events: 0 serious events

Other events: 50 other events

Deaths: 0 deaths

Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1)

Serious events: 0 serious events

Other events: 99 other events

Deaths: 0 deaths

Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3)

Serious events: 0 serious events

Other events: 107 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Albendazole n=243 participants at risk Single dose of Albendazole 400mg	Single Dose Albendazole-Ivermectin Fixed Dose Co-formulation (FDCx1) n=381 participants at risk Single dose 400mg Albendazole- 9mg Ivermectin for participants \<45 kg of body weight Single dose 400mg Albendazole- 18mg Ivermectin for participants \>= 45 kg of body weight	Daily Dose of Albendazole-Ivermectin FIxed Dose Co-formulation for Three Consecutive Days (FDCx3) n=377 participants at risk Daily dose of 400mg Albendazole- 9mg Ivermectin for 3 consecutive days for participants \<45 kg of body weight Daily dose of 400mg Albendazole- 18mg Ivermectin for 3 consecutive days for participants \>= 45 kg of body weight
Gastrointestinal disorders Abdominal pain	9.5% 23/243 • Number of events 24 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.	13.6% 52/381 • Number of events 60 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.	12.5% 47/377 • Number of events 52 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.
Nervous system disorders Headache	2.9% 7/243 • Number of events 7 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.	5.2% 20/381 • Number of events 21 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.	3.7% 14/377 • Number of events 18 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.
Gastrointestinal disorders Diarrhoea	2.1% 5/243 • Number of events 5 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.	4.5% 17/381 • Number of events 17 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.	3.2% 12/377 • Number of events 14 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.
Gastrointestinal disorders Vomiting	1.6% 4/243 • Number of events 4 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.	2.6% 10/381 • Number of events 10 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.	3.2% 12/377 • Number of events 15 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.
Gastrointestinal disorders Nausea	0.82% 2/243 • Number of events 2 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.	1.6% 6/381 • Number of events 6 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.	4.5% 17/377 • Number of events 18 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.
Respiratory, thoracic and mediastinal disorders Cough	0.41% 1/243 • Number of events 1 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.	1.0% 4/381 • Number of events 4 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.	2.7% 10/377 • Number of events 10 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.
Gastrointestinal disorders Parasitic gastroenteritis	1.2% 3/243 • Number of events 5 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.	0.79% 3/381 • Number of events 3 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.	1.1% 4/377 • Number of events 4 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.6% 4/243 • Number of events 4 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.	0.52% 2/381 • Number of events 2 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.	1.3% 5/377 • Number of events 5 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.
Respiratory, thoracic and mediastinal disorders Upper respiratory track infection	0.82% 2/243 • Number of events 2 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.	1.0% 4/381 • Number of events 4 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.	0.53% 2/377 • Number of events 2 • For the safety evaluation on treatment days, participants stayed at the sites for 3 h after drug administration.Safety was also actively monitored on days 1, 2, 7, and 21 after taking the medication. Adverse events were reported for the intention-to-treat (ITT) population comprising participants from both Phase II and Phase III (n = 1001), regardless of baseline infection type (T. trichiura, hookworms, or S. stercoralis). All events were documented systematically following treatment administration.

Additional Information

Jose Muñoz

Instituto de Salud Global de Barcelona - ISGLOBAL

Phone: +34608774071

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60