Hookworm InfectionPhase 4TricombiNCT03278431
Triple Combinations Against Hookworm Infections in Lao
A Phase 4 study testing Albendazole, Pyrantel Pamoate and Oxantel Pamoate in people with Hookworm Infection, run by Swiss Tropical & Public Health Institute at 1 site in Laos.
Trial summary
More than one billion people are infected with soil-transmitted helminths (STH, A. lumbricoides, hookworm or Trichuris trichiura). Preventive chemotherapy - i.e. annual or biannual treatment of at-risk populations with albendazole or mebendazole is the current strategy against STH. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Hookworm Infection
- What is being tested?
- Albendazole, Pyrantel Pamoate and Oxantel Pamoate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteLaos
- Study dates
- 27 Sep 2017to 1 Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Written informed consent signed by parents and/or legal representative; and a verbal assent (children <12 years) or signed assent (children ≥12 years), according to Lao regulations.
- Able and willing to be examined by a study physician at the beginning of the study.
- Able and willing to provide two stool samples at the beginning (baseline) and two to three weeks after treatment (follow-up).
- Positive for hookworm eggs in the stool.
- Absence of major systemic illnesses, e.g. diabetes, severe anemia as assessed by a medical doctor, upon initial clinical assessment.
- No known or reported history of chronical illness as cancer, diabetes, chronic heart, liver or renal disease.
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- No recent anthelminthic treatment (within past 4 weeks).
- No known allergy to study medications (e.g. albendazole, mebendazole, pyrantel pamoate, oxantel pamoate).
- Negative pregnancy test (girls ≥12 years)
Who cannot join
- No written informed consent by parents and/or legal representative and no verbal assent (children <12 years) or signed assent (children ≥12 years).
- Presence of major systemic illnesses, e.g. diabetes, severe anemia as assessed by a medical doctor, upon initial clinical assessment.
- History of acute or severe chronic disease.
- Recent use of anthelminthic drug (within past 4 weeks).
- Attending other clinical trials during the study.
- Negative diagnostic result for hookworm eggs in the stool.
- Positive pregnancy test (girls ≥12 years)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Different Drug Combinations Against Hookworm Infection in School-aged Children in the Lao People's Democratic Republic, a Single Blind, Randomised Controlled Trial
More than one billion people are infected with soil-transmitted helminths (STH, A. lumbricoides, hookworm or Trichuris trichiura). Preventive chemotherapy - i.e. annual or biannual treatment of at-risk populations with albendazole or mebendazole is the current strategy against STH. However, the efficacy of both drugs is only moderate against hookworm and low against T. trichiura. For increasing the efficacy and to avoid drug resistance, new drugs or the combination of different drugs is the way forward.
In this randomised controlled trial, we assess the efficacy (based on cure rates) of different drug combinations in school-aged children in Lao. 420 hookworm positive children will be treated: 140 with albendazole-oxantel pamoate, 140 with albendazole-pyrantel pamoate-oxantel pamoate treatment arms, 70 with pyrantel pamoate-oxantel pamoate and 70 with mebendazole-pyrantel pamoate-oxantel pamoate. Two stool samples will be collected at baseline and follow-up (14-21 days after treatment) and analysed with Kato-Katz.
Read the detailed description
More than one billion people are infected with A. lumbricoides, hookworm or Trichuris trichiura, the so-called soil-transmitted helminths (STH). Preventive chemotherapy - i.e. annual or biannual treatment of at-risk populations, is the current strategy against STH advocated by the World Health Organization. However, the currently used drugs albendazole and mebendazole have only moderate efficacy against hookworm and low against T. trichiura. The main challenge is their temporal decrease in efficacy, which might be associated with drug resistance, as it was shown in veterinary medicine. For increasing the efficacy and to avoid drug resistance, new drugs or the combination of different drugs is the way forward.
The primary objective of this study is to assess the efficacy (based on cure rates [CR]) of the three combinations, i.e. albendazole-oxantel pamoate, pyrantel pamoate-oxantel pamoate and albendazole-pyrantel pamoate-oxantel pamoate in school-aged children infected with hookworms in Laos. Secondary objectives include; i) a proof of concept, investigating the difference between the two triple combinations albendazole-pyrantel pamoate-oxantel pamoate versus mebendazole-pyrantel pamoate-oxantel pamoate (based on CRs), ii) egg reduction rates (ERR) against hookworm and ERRs/CRs against A. lumbricoides and T. trichiura and iii) tolerability of the 4 combinations.
Two stool samples will be collected from school-aged children (age 6-15) at baseline. 420 hookworm positive children will be treated: 140 with albendazole-oxantel pamoate, 140 with albendazole-pyrantel pamoate-oxantel pamoate, 70 with pyrantel pamoate-oxantel pamoate and 70 with mebendazole-pyrantel pamoate-oxantel pamoate treatment arms The medical history of the participating children will be assessed with a standardized questionnaire, in addition to a clinical examination carried out by the study physician on the treatment day. Children will be interviewed before treatment for clinical symptoms and 3 and 24 hours after treatment about the occurrence of adverse events. The efficacy of the treatment will be determined 14-21 days post-treatment by collecting another two stool samples. All stool samples will be examined with duplicated Kato-Katz thick smears.
- Conditions
- Hookworm Infection
- Being tested
- Albendazole, Pyrantel Pamoate, Oxantel Pamoate, Mebendazole
- Medical subject headings
- Hookworm Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbendazoleDrug
Albendazole (400 mg) from Janssen, donated by the World Health Organization
Pyrantel PamoateDrug
Pyrantel pamoate (20 mg/kg), will be purchased by the World Health Organization
Oxantel PamoateDrug
Oxantel pamoate (20mg/kg) will be produced by the University of Basel
MebendazoleDrug
Mebendazole (500 mg) from GlaxoSmithKline, donated by the World Health Organization
| Study group | Role | What they receive |
|---|---|---|
| Albendazole triple combi | Active comparator | Albendazole (400 mg) + pyrantel pamoate (20 mg/kg) + oxantel pamoate (20 mg/kg) Receives: Drug: Albendazole; Drug: Pyrantel Pamoate; Drug: Oxantel Pamoate |
| Pyrantel pamoate double combi | Experimental | Pyrantel pamoate (20 mg/kg) + oxantel pamoate (20 mg/kg) Receives: Drug: Pyrantel Pamoate; Drug: Oxantel Pamoate |
| Albendazole double combi | Experimental | Albendazole (400 mg) + oxantel pamoate (20 mg/kg) Receives: Drug: Albendazole; Drug: Oxantel Pamoate |
| Mebendazole triple combi | Experimental | Mebendazole (500mg) + pyrantel pamoate (20 mg/kg) + oxantel pamoate (20 mg/kg) Receives: Drug: Pyrantel Pamoate; Drug: Oxantel Pamoate; Drug: Mebendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rates of three drug combinations
to comparatively assess the efficacy (based on cure rates, CR) i) albendazole-oxantel pamoate, ii) pyrantel pamoate-oxantel pamoate, iii) albendazole-pyrantel pamoate-oxantel pamoate in school-aged children infected with hookworms.
Measured: 14-21 days after treatment
Secondary outcomes (3)
Cure rates against hookworm of the two triple combinations
To assess the CRs against hookworm of albendazole-pyrantel pamoate-oxantel pamoate versus mebendazole-pyrantel pamoate-oxantel pamoate (proof of concept)
Measured: 14-21 days after treatment
Egg reduction rates (ERR) against hookworm and ERRs/CRs against A. lumbricoides and T. trichiura
Assessing the egg reduction rates (ERR) against hookworm and ERRs and cure rates (CR) against A. lumbricoides and T. trichiura
Measured: 14-21 days after treatment
Incidence of adverse events 3 and 24 hours after treatment
Participants will be interviewed using a standardized questionnaire, before treatment for clinical symptoms and 3 and 24 hours after treatment about the occurrence of adverse events.
Measured: 3 and 24 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start27 Sep 2017
- Primary completion17 Nov 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hookworm InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Keiser, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278431
- Sponsor's protocol ID
- TRICOMBI01032017
- Acronym
- Tricombi
- Status last verified
- May 2018
- First submitted
- 6 Sep 2017
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moser W, Sayasone S, Xayavong S, Bounheuang B, Puchkov M, Huwyler J, Hattendorf J, Keiser J. Efficacy and tolerability of triple drug therapy with albendazole, pyrantel pamoate, and oxantel pamoate compared with albendazole plus oxantel pamoate, pyrantel pamoate plus oxantel pamoate, and mebendazole plus pyrantel pamoate and oxantel pamoate against hookworm infections in school-aged children in Laos: a randomised, single-blind trial. Lancet Infect Dis. 2018 Jul;18(7):729-737. doi: 10.1016/S1473-3099(18)30220-2. Epub 2018 Apr 16.
PubMed 29673735
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Drug Combinations Against Hookworm Infection in School-aged Children in the Lao People's Democratic Republic, a Single Blind, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03278431
- Acronym / sponsor ID
- Tricombi / TRICOMBI01032017
- Conditions
- Hookworm Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Study start
- 27 Sep 2017 (actual)
- Primary completion
- 17 Nov 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 11 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
More than one billion people are infected with soil-transmitted helminths (STH, A. lumbricoides, hookworm or Trichuris trichiura). Preventive chemotherapy - i.e. annual or biannual treatment of at-risk populations with albendazole or mebendazole is the current strategy against STH. However, the efficacy of both drugs is only moderate against hookworm and low against T. trichiura. For increasing the efficacy and to avoid drug resistance, new drugs or the combination of different drugs is the way forward.
In this randomised controlled trial, we assess the efficacy (based on cure rates) of different drug combinations in school-aged children in Lao. 420 hookworm positive children will be treated: 140 with albendazole-oxantel pamoate, 140 with albendazole-pyrantel pamoate-oxantel pamoate treatment arms, 70 with pyrantel pamoate-oxantel pamoate and 70 with mebendazole-pyrantel pamoate-oxantel pamoate. Two stool samples will be collected at baseline and follow-up (14-21 days after treatment) and analysed with Kato-Katz.
Detailed description
More than one billion people are infected with A. lumbricoides, hookworm or Trichuris trichiura, the so-called soil-transmitted helminths (STH). Preventive chemotherapy - i.e. annual or biannual treatment of at-risk populations, is the current strategy against STH advocated by the World Health Organization. However, the currently used drugs albendazole and mebendazole have only moderate efficacy against hookworm and low against T. trichiura. The main challenge is their temporal decrease in efficacy, which might be associated with drug resistance, as it was shown in veterinary medicine. For increasing the efficacy and to avoid drug resistance, new drugs or the combination of different drugs is the way forward.
The primary objective of this study is to assess the efficacy (based on cure rates [CR]) of the three combinations, i.e. albendazole-oxantel pamoate, pyrantel pamoate-oxantel pamoate and albendazole-pyrantel pamoate-oxantel pamoate in school-aged children infected with hookworms in Laos. Secondary objectives include; i) a proof of concept, investigating the difference between the two triple combinations albendazole-pyrantel pamoate-oxantel pamoate versus mebendazole-pyrantel pamoate-oxantel pamoate (based on CRs), ii) egg reduction rates (ERR) against hookworm and ERRs/CRs against A. lumbricoides and T. trichiura and iii) tolerability of the 4 combinations.
Two stool samples will be collected from school-aged children (age 6-15) at baseline. 420 hookworm positive children will be treated: 140 with albendazole-oxantel pamoate, 140 with albendazole-pyrantel pamoate-oxantel pamoate, 70 with pyrantel pamoate-oxantel pamoate and 70 with mebendazole-pyrantel pamoate-oxantel pamoate treatment arms The medical history of the participating children will be assessed with a standardized questionnaire, in addition to a clinical examination carried out by the study physician on the treatment day. Children will be interviewed before treatment for clinical symptoms and 3 and 24 hours after treatment about the occurrence of adverse events. The efficacy of the treatment will be determined 14-21 days post-treatment by collecting another two stool samples. All stool samples will be examined with duplicated Kato-Katz thick smears.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Albendazole triple combi | Active comparator | Drug: Albendazole, Drug: Pyrantel Pamoate, Drug: Oxantel PamoateAlbendazole (400 mg) + pyrantel pamoate (20 mg/kg) + oxantel pamoate (20 mg/kg) |
| Pyrantel pamoate double combi | Experimental | Drug: Pyrantel Pamoate, Drug: Oxantel PamoatePyrantel pamoate (20 mg/kg) + oxantel pamoate (20 mg/kg) |
| Albendazole double combi | Experimental | Drug: Albendazole, Drug: Oxantel PamoateAlbendazole (400 mg) + oxantel pamoate (20 mg/kg) |
| Mebendazole triple combi | Experimental | Drug: Pyrantel Pamoate, Drug: Oxantel Pamoate, Drug: MebendazoleMebendazole (500mg) + pyrantel pamoate (20 mg/kg) + oxantel pamoate (20 mg/kg) |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Written informed consent signed by parents and/or legal representative; and a verbal assent (children <12 years) or signed assent (children ≥12 years), according to Lao regulations.
- Able and willing to be examined by a study physician at the beginning of the study.
- Able and willing to provide two stool samples at the beginning (baseline) and two to three weeks after treatment (follow-up).
- Positive for hookworm eggs in the stool.
- Absence of major systemic illnesses, e.g. diabetes, severe anemia as assessed by a medical doctor, upon initial clinical assessment.
Key exclusion criteria (7 listed)
- No written informed consent by parents and/or legal representative and no verbal assent (children <12 years) or signed assent (children ≥12 years).
- Presence of major systemic illnesses, e.g. diabetes, severe anemia as assessed by a medical doctor, upon initial clinical assessment.
- History of acute or severe chronic disease.
- Recent use of anthelminthic drug (within past 4 weeks).
- Attending other clinical trials during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlbendazoleAlbendazole (400 mg) from Janssen, donated by the World Health Organization | Drug | Albendazole double combi, Albendazole triple combi |
| Pyrantel PamoatePyrantel pamoate (20 mg/kg), will be purchased by the World Health Organization | Drug | Albendazole triple combi, Mebendazole triple combi, Pyrantel pamoate double combi |
| Oxantel PamoateOxantel pamoate (20mg/kg) will be produced by the University of Basel | Drug | Albendazole double combi, Albendazole triple combi, Mebendazole triple combi, Pyrantel pamoate double combi |
| MebendazoleMebendazole (500 mg) from GlaxoSmithKline, donated by the World Health Organization | Drug | Mebendazole triple combi |
Primary outcome
Cure rates of three drug combinations
Time frame: 14-21 days after treatment
to comparatively assess the efficacy (based on cure rates, CR) i) albendazole-oxantel pamoate, ii) pyrantel pamoate-oxantel pamoate, iii) albendazole-pyrantel pamoate-oxantel pamoate in school-aged children infected with hookworms.
3 secondary outcomes
Cure rates against hookworm of the two triple combinations
Time frame: 14-21 days after treatment
Egg reduction rates (ERR) against hookworm and ERRs/CRs against A. lumbricoides and T. trichiura
Time frame: 14-21 days after treatment
Incidence of adverse events 3 and 24 hours after treatment
Time frame: 3 and 24 hours after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Derived from this study: PubMed 29673735Moser W, Sayasone S, Xayavong S, Bounheuang B, Puchkov M, Huwyler J, Hattendorf J, Keiser J. Efficacy and tolerability of triple drug therapy with albendazole, pyrantel pamoate, and oxantel pamoate compared with albendazole plus oxantel pamoate, pyrantel pamoate plus oxantel pamoate, and mebendazole plus pyrantel pamoate and oxantel pamoate against hookworm infections in school-aged children in Laos: a randomised, single-blind trial. Lancet Infect Dis. 2018 Jul;18(7):729-737. doi: 10.1016/S1473-3099(18)30220-2. Epub 2018 Apr 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Albendazole, Pyrantel Pamoate and Oxantel Pamoate in people with Hookworm Infection, run by Swiss Tropical & Public Health Institute at 1 site in Laos.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Laos. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rates of three drug combinations (time frame: 14-21 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03278431, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.